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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 130 out of 172

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VAERS ID: 1425718 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4835 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021717058

Write-up: Unconscious; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300083596. A 58-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 26May2021 (Lot Number: EY4835) as dose number unknown, single (at age of 58-years-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unconscious (death, medically significant) on 03Jun2021 07:30. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unconscious


VAERS ID: 1425721 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Feeling cold, Hot flush, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021680776

Write-up: hot and cold flashes alternately; hot and cold flashes alternately; stomach ache; stopped breathing in one second; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28May2021, the reporter''s dad died, who had been treated with a second dose of the Pfizer vaccine a few hours earlier. The reporter informed that the patient didn''t get sick with anything, he didn''t complain about any ailments before. This was confirmed by the patient''s record in the clinic he belonged to. A few hours after vaccination, in the morning at approximately 3:30, had hot and cold flashes alternately, had stomach ache (never happened before). When the reporter''s mother called the ambulance service, she received information that it was normal after the vaccination, she was refused to come, considering it an unnecessary action and stressing that it could be like this after the vaccination, which also reassured the parents that it would probably pass soon. They were ordered to come to the clinic after 7:00 am. Unfortunately, after an hour, the patient stopped breathing in one second and died immediately. Despite being resuscitated by the doctors from the ambulance that came on the second call, the patient could not be saved. Practically before the arrival of the ambulance, the patient died. The overlap with previous vaccination was very large and very suspicious. The GP who wrote out the patient''s death certificate reported the NOP. The reporter informed that they stayed with the family tragedy, believing in the manufacturer''s and the government''s assurances that vaccines were safe, and meanwhile it was a medical experiment (which, moreover, results from the leaflets you attach to patients). However, there was no information on the leaflet that complications from the vaccine can cause or contribute to death. The outcome of the event stopped breathing in one second was fatal, while unknown for the rest of the events. The patient died on 28May2021. It was not reported if an autopsy was performed. Follow-up activities are possible, information on the batch number has been requested.; Reported Cause(s) of Death: stopped breathing in one second


VAERS ID: 1425723 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 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: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021674465

Write-up: Sudden death, cause unknown; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB; the Regulatory Authority report number is PL-URPL-3-703-2021. A 70-year-old female patient received BNT162B2 (COMIRNATY) intramuscular, administered in the left arm on 21May2021 15:00 (batch/lot number: FC0681 and expiration date: 21Sep2021) at 70 years old as DOSE 2, 0.3mL SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took Comirnaty via an unspecified route of administration on an unknown date (batch/lot number unknown) as DOSE 1, SINGLE for COVID-19 immunization without side effects. The patient experienced sudden death, cause unknown (sudden death) on 22May2021 23:10. It was reported that the patient died within 48 hours of vaccination. Only the immediate cause was given in the death certificate: other unknown urgent cause also reported as other sudden death, cause unknown. The primary care physician reporting informed that the patient has not received treatment for chronic diseases, and that he would not apply for an autopsy. First vaccination was without side effects, second vaccination was without contraindications. On 02Jun2021, the Agency informed that he did not have any information whether the patient had experienced side effects between administration of the vaccine and death. In the course of the investigation (in an interview with the primary health care physician reporting), it was found that the patient was vaccinated on 21May2021 at 15:00 and on 22May2021, she was found around 20:00 on the sidewalk by a random passerby. The ambulance service was called to the scene and conducted a rescue operation, which ended with the patient''s death at 23:10, the cause has not been established. The death certificate lists one cause (another unknown cause). An autopsy was not performed. Senders comment: Death occurred 2 days after vaccination. A patient with no aggravating medical history, it cannot be ruled out that the vaccine contributed to her death. There is a time relationship between vaccination and the occurrence of side effects. The person reporting qualified it as severe. Regulatory Authority assessed as heavy. Assessment: The Agency (Source of assessment) assessed the event "Other sudden death, cause unknown" as Possibly related to Comirnaty through WHO Method of assessment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Other sudden death, cause unknown


VAERS ID: 1425724 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Renal failure, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (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: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021674463

Write-up: respiratory failure; kidney failure; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number PL-URPL-3-704-2021. A 76-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular, administered in the left arm on 12Mar2021 12:22 (batch/lot number ER7812 and expiry date 16Mar2021) at 76 years of age as dose 2, 0.3 ml single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Mar2021 11:00, the patient experienced respiratory failure, kidney failure. The physician informed that the patient died on 14Mar2021 at 11:00 am in hospital; renal failure, respiratory failure. The health outcome was death. The events were also reported serious (hospitalization). The patient died on 14Mar2021 at 11:00 am. It was unknown if an autopsy was performed. Sender''s comments: death occurred on day 2 after vaccination. No information was available on the patient''s medical history. URPL requested additional information. There is a temporal relationship between vaccination and adverse events. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: respiratory failure; kidney failure


VAERS ID: 1425725 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death
SMQs:, Cardiac failure (narrow), 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: Spinal osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021675199

Write-up: I50 - Heart failure; R98 - Unattended death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PL-URPL-3-707-2021]. A 63-year-old male patient received his second dose of BNT162B2 (COMIRNATY; lot number: FC0681, expiration date: 01Sep2021), intramuscular on 21May2021 10:42 (at the age of 63-years-old) at dose 2, single in the left arm for COVID-19 immunisation. Medical history included degeneration of the spine. The patient''s concomitant mediations were not reported. It was reported that on 21May2021, the patient showed no contraindications for vaccination against COVID-19. There were no side effects before the patient diead. On 21May2021 22:30, the patient died due to R98- unattended death, direct cause was I50- Heart failure, unexpected death, and indirect cause was R99- Inaccurate or unknown causes of death. The patient''s documentation does not provide information on the medications taken on a regular basis. It was unknown if the patient underwent autopsy. Outcome of all the events was fatal. A causal relationship between the BNT162B2 and events unattended death and heart failure was assessed based on the following: Source of assessment: Regulatory Authority, Method of Assessment: WHO, and Result of assessment was possible. Sender Comment: The patient was not chronically treated, the death occurred 10 hours after vaccination, so the role of the vaccine cannot be excluded. The person reporting an undesirable post-vaccination reaction qualified it as severe. Regulatory Authority assessed the "an undesirable post-vaccination reaction" as heavy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: R98 - Unattended death; I50 - Heart failure


VAERS ID: 1425758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiparous
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021724830

Write-up: several hours after second dose of Pfizer vaccine she was dead; This is a spontaneous report from a contactable consumer received from media web page, internet source. A 39-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY) at single dose intramuscular on 14Jun2021 for COVID-19 immunisation. Patient was mother of two children. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation. Patient died in age 39 on 15Jun2021 (Tuesday), several hours after vaccination. The clinical course was reported as follows: One day she was full of life and after several hours after second dose of Pfizer vaccine she was dead. It is fifth death here in the country which is investigated as potentially caused by vaccine administration against coronavirus. Authorities investigated all cases and determined what role played vaccine in such cases. Patient was at work on Monday full of life. Around midday she went together with her husband to hospital to be vaccinated by the second dose of Pfizer vaccine. They went together with the husband. She had common reaction after the first dose of vaccine. It was unknow whether she had had health problems. Deputy of boss says: "I was informed about it through text message from her husband that he had send me at night from Monday to Tuesday". Connection to the death of the young mother excluded regulatory authority. Spokesperson of regulatory authority: "In this moment we definitely exclude that the death could by connected with the vaccination. In this case laboratory examinations have been indicated, based on results the case will be consulted with the Health Care Surveillance Authority and State Institute for Drug Control." Outcome of the event was fatal.; Reported Cause(s) of Death: several hours after second dose of Pfizer vaccine she was dead


VAERS ID: 1425760 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
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: TRPFIZER INC2021718328

Write-up: passed away 3 days after receiving the Biontech vaccine; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number 65392], license party for [BNT162B2]. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed away 3 days after receiving the Biontech vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: passed away 3 days after receiving the Biontech vaccine


VAERS ID: 1427321 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: ZAPFIZER INC2021676284

Write-up: Death; General malaise; Fever; Shivering; This is a spontaneous report received from a non-contactable consumer from the Regulatory Authority (Regulatory authority number ZA-SAHPRA-202106041155342490-THXSZ). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FA7812), via an unspecified route of administration on 28May2021 (at the age of 74-years-old) as dose number unknown, single for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. On 03Jun2021, the patient experienced general malaise, fever and shivering. The patient experienced death on 03Jun2021. The outcome of general malaise, fever and shivering was unknown. The outcome of death was fatal. The cause of death was unknown. It was unknown if an autopsy was performed. No further information was provided at the time of this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1427322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate, Hypertension, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIMEPIRIDE; ENALAPRIL; AMLODIPINE; ASPIRIN (E.C.); HALOPERIDOL; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: temperature; Result Unstructured Data: Test Result:32.4 Centigrade; Test Date: 20210604; Test Name: temperature; Result Unstructured Data: Test Result:34 Centigrade; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:70 bpm; Test Date: 20210604; Test Name: pulse; Result Unstructured Data: Test Result:89 bpm; Test Date: 20210603; Test Name: respiration rate; Result Unstructured Data: Test Result:20/min; Test Date: 20210604; Test Name: respiration rate; Result Unstructured Data: Test Result:22/min; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:150/78 mmHg; Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:181/110 mmHg
CDC Split Type: ZAPFIZER INC2021676429

Write-up: Death; Elevated blood pressure; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 03Jun2021 11:15 (Batch/Lot Number: FC3558; Expiration Date: Sep2021) dose 1, single for covid-19 immunization. The diluent batch# L1945; exp date May2023. The vaccine was reconstituted on 03Jun2021. Medical history included hypertension and diabetes mellitus. Concomitant medications included metformin, glimepiride, enalapril, amlodipine, acetylsalicylic acid (ASPIRIN), haloperidol and hydrochlorothiazide. The patient was reported to have died on 04Jun2021, prior to that, the patient had an elevated blood pressure (hypertension) on 04Jun2021, post vaccination vital sign - temperature 34 degrees celsius (body temperature decreased). The patient died on 04Jun2021. It was not reported if an autopsy was performed; the death was reported to have been classified as natural death by the paramedics. The outcome of the event elevated blood pressure was unknown. Department report dated 05 Jun2021: The case was assessed/screened pre vaccination for COVID-19 Symptoms on 3Jun2021 and reported not to be having any signs. Pre-vaccination her vital signs were BP 150/78, temperature 32.4d egrees, pulse 70 beats per minute and respiration rate 20 per minute. Post vaccination ON 04Jun2021 the late reported to be feeling well but her post vaccination vital signs were BP 181/110, Temperature 34 degrees Celsius, pulse 89 beats per minutes and respiration rate 22 per minute. The case was advised to stay for the vital signs to be repeated and transferred if BP was not subsiding, but she requested to be released. On interview with the family, it was alleged that she did not report any pains before going to bed. The family discovered that she was no longer breathing in the morning on 4Jun2021 at 11:00 am and was certified dead by the paramedics at 14:00. The family then notified the Agency supervisor of her demise on 4 June 2021. The body was collected by the funeral undertaker, and no COVID-19 sample was collected at home for this case to rule out the COVID-19 disease. During the investigation packs of tablets that she collected at the clinic in March were still sealed to show that she was not taking her treatment as prescribed. The case is a known hypertensive and diabetic who defaulted her treatment as there were packs of sealed treatment and did not return to the clinic for her follow-up treatment in May 2021. Therefore, the death is not classified as vaccine related adverse event following immunization death. The death was classified under natural causes of death.; Sender''s Comments: Based on the current available information, the events Death from natural causes and Blood pressure high are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1427352 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Hypotonia, Mycobacterium tuberculosis complex test, Pain, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: Body temperature; Result Unstructured Data: Test Result:mild fever; Test Date: 20210611; Test Name: mycobacterium tuberculosis complex test; Test Result: Positive ; Comments: for TB
CDC Split Type: ZAPFIZER INC2021729184

Write-up: Unknown cause of death; Feeling flaccid; Minor body aches; Mild fever; This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: FA5715, expiration date: 20May2021), at the age of 74 years old, on 18May2021 13:44 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling flaccid, minor body aches and mild fever on 18May2021 20:00. The patient experienced unknown cause of death on 10Jun2021. The patient underwent lab tests and procedures which included body temperature: mild fever on 18May2021 and mycobacterium tuberculosis complex test: positive for TB on 11Jun2021. Therapeutic measures were taken as a result of events feeling flaccid, minor body aches and mild fever. The patient was reported to have passed away in the morning of 10Jun2021. It was not reported if an autopsy was performed. The outcome of the event unknown cause of death was fatal. The outcome of other events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the plausible temporal relation and limited information, the association between the events of unknown cause of death, flaccidity, aches and fever and the suspect product of BNT162B2 cannot be completely ruled out. 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: 1427353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021730778

Write-up: vaccinated on the 08Jun2021 same clinic also had complications she unfortunately died today.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated on the 08Jun2021 at the same clinic also had complications in Jun2021, she unfortunately died (death, hospitalization). The patient died on 17Jun2021. It was not reported if an autopsy was performed. No further information was available at the time of this report.; Reported Cause(s) of Death: vaccinated on the 08Jun2021 same clinic also had complications she unfortunately died today.


VAERS ID: 1427482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anomaly of gallbladder (Old surgical defect of the gall bladder); Bladder hypertrophy (Muscular hypertrophy of the urinary bladder (called trabecular urinary bladder)); Cardiac dilatation (Dilatation of all heart cavities); Coronary artery sclerosis; Emphysema pulmonary (Chronic emphysema); Generalised arteriosclerosis; Goitre nodular (Nodular colloid goiter with regressive changes); Left ventricular hypertrophy; Nephrosclerosis arteriolar (Arteriolosclerosis of both kidneys); Peritonitis (Chronic adhesive peritonitis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021681902

Write-up: Lung embolism; Deep vein thrombosis leg; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (regulatory authority number: AT-BASGAGES-2021-30681). A 73-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number and expiry date were not reported), intramuscular on 05May2021 as 1ST DOSE, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included left ventricular hypertrophy, cardiac dilatation (Dilatation of all heart cavities), emphysema pulmonary (Chronic emphysema), coronary artery sclerosis, generalised arteriosclerosis, nephrosclerosis arteriolar (Arteriolosclerosis of both kidneys), bladder hypertrophy (Muscular hypertrophy of the urinary bladder (called trabecular urinary bladder)), goitre nodular (Nodular colloid goiter with regressive changes), anomaly of gallbladder (Old surgical defect of the gall bladder), peritonitis (Chronic adhesive peritonitis). Concomitant medications were not reported. The patient experienced lung embolism (death) on May2021 and deep vein thrombosis leg (life threatening) on May2021. Outcome of the event deep vein thrombosis leg was not recovered, while outcome of lung embolism was fatal. The patient died on 10May2021. An autopsy was performed, and results were not provided. The event lung embolism was assessed as fatal, while the event deep vein thrombosis leg was assessed as life-threatening. The reporter assessed the casual relationship between Comirnaty and all reported events as possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1427484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Alcoholism (Alcoholism)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021728598

Write-up: unclear death (presumably myocardial infarction), judicial med. Autopsy requested. Result not known to date; unclear death (presumably myocardial infarction), judicial med. Autopsy requested. Result not known to date; This is a spontaneous report from a contactable physician downloaded from an Agency -WEB, regulatory authority number AT-BASGAGES-2021-31739. A 58-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 04Jun2021 (Batch/Lot Number: FC2473) as dose 1, single for covid-19 immunization. Medical history included ongoing alcoholism. The patient''s concomitant medications were not reported. On 05Jun2021, the patient had myocardial infarction and death. It was reported that "unclear death (presumably myocardial infarction), judicial med. Autopsy requested. Result not known to date". Both events resulted in death. An autopsy was performed, and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown


VAERS ID: 1427485 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ATPFIZER INC2021728625

Write-up: Death NOS; Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the regulatory authority-WEB AT-BASGAGES-2021-31882. A 87-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown), via intramuscular on 15Apr2021 (at the age of 87-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced nausea. On an unspecified date, the patient experienced death NOS. The autopsy results were not reported. Treatment was received for the event nausea. The event resulted in emergency room visit. The outcome of the event for nausea was not recovered while for the other event was fatal. Sender comment included BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1427487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021749699

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable HCP via the regulatory authority. Regulatory authority report number is 569171. A 86 year-old female patient (Unknown pregnant) received an unspecified dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced pulmonary embolism. The patient died on an unspecified date. The cause of death was pulmonary embolism. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1427506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Fibrin D dimer, Fibrin D dimer increased, Leukocytosis, Neutrophilia, Oxygen saturation decreased, Platelet count, Pulmonary embolism, SARS-CoV-2 antibody test, Smear test, Thrombocytopenia, Urinary tract infection
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (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: STEOVIT D3; DAFALGAN; FOLAVIT; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker; Thrombosis retinal vein; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: CRP; Result Unstructured Data: Test Result:in the context of probably urinary infection; Comments: in the context of probably urinary infection; Test Date: 20210525; Test Name: ransthoracic cardiac ultrasound; Result Unstructured Data: Test Result:table of massive pulmonary embolism; Comments: table of massive pulmonary embolism; Test Date: 20210525; Test Name: D-dimer; Result Unstructured Data: Test Result:20400- 46000; Comments: 20400- 46000; Test Date: 20210525; Test Name: platelets; Result Unstructured Data: Test Result:Neutrophilic leukocytosis; Comments: Neutrophilic leukocytosis; Test Name: Covid IgG serology; Test Result: Positive ; Test Name: Covid smear; Test Result: Negative
CDC Split Type: BEPFIZER INC2021688105

Write-up: Neutrophilic leukocytosis; Desaturation of sudden onset on 25May; Urinary infection; Neutrophilic leukocytosis; Massive pulmonary embolism; hypoplatelet; D-dimers 20400- 46000; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-93787. A 82-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Batch/Lot Number: FA7812) as dose 2, single for covid-19 immunisation. Medical history included transient ischaemic attack, retinal vein thrombosis, tobacco user. The patient previous took first dose of bnt162b2 (COMIRNATY) on an unspecified date for for covid-19 immunisation. Concomitant medication(s) included calcium carbonate, colecalciferol (STEOVIT D3); paracetamol (DAFALGAN); folic acid (FOLAVIT); bromazepam. The patient experienced neutrophilic leukocytosis, desaturation of sudden onset, urinary infection, massive pulmonary embolism, hypoplatelet, d-dimers 20400- 46000 on 25May2021, seriousness criteria was death. No treatment was received. The patient underwent lab tests and procedures which included c-reactive protein: in the context of probably urinary infection, echocardiogram: table of massive pulmonary embolism, fibrin d dimer: 20400- 46000, platelet count: neutrophilic leukocytosis all on 25May2021, sars-cov-2 antibody test: positive, smear test: negative. The patient died on 26May2021. It was not reported if an autopsy was performed. Reporter comment : Treatment - No Evolution of the ADR - Death Examinations - Transthoracic cardiac echography: table of massive pulmonary embolism Biology: D-dimer 20400- 46000 platelets-Neutrophilic leukocytosis and CRP in the context of probably urinary tract infection Covid IgG positive serology Covid smear negative No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Treatment - No Evolution of the ADR - Death Examinations - Transthoracic cardiac echography: table of massive pulmonary embolism Biology: D-dimer 20400- 46000 platelets-Neutrophilic leukocytosis and CRP in the context of probably urinary tract infection Covid IgG positive serology Covid smear negative; Reported Cause(s) of Death: Neutrophilic leukocytosis; desaturation of sudden onset; Urinary infection; Neutrophilic leukocytosis; Massive pulmonary embolism; hypoplatelet; D-dimers 20400- 46000


VAERS ID: 1427513 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-29
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Agitation, Anaemia, Asthenia, Balance disorder, Confusional state, Death, Haemoglobin, Nervous system disorder, Oxygen saturation, Oxygen saturation decreased, Pallor, Speech disorder
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 122
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (anemia that has been stable until then)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.1; Test Date: 20210129; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:oxygen tension 80; Comments: decreased
CDC Split Type: BEPFIZER INC2021688153

Write-up: passing away; Neurological problem; oxygen tension80; Weak; Loss of balance; Anemia (6.1 hemoglobin); Confusion; throwing things; babbling unintelligible; Agitation; Pale; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-94843, received by the authorities on 04Jun2021. A 90-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included anaemia (anemia that has been stable until then). The patient''s concomitant medications were not reported. The patient experienced passing away, neurological problem, oxygen tension80, weak, loss of balance, anemia (6.1 hemoglobin), confusion, throwing things, babbling unintelligible , agitation and pale, all on 29Jan2021 with fatal outcome. All events reported as serious with criteria death and life threatening. The patient underwent lab tests which included haemoglobin: 6.1 on 29Jan2021, oxygen saturation: oxygen tension 80 on 29Jan2021 (decreased). The patient died on 01Jun2021. It was not reported if an autopsy was performed. Reporters Comment: Treatment - Unknown Evolution of the ADR - Deceased Examinations - anemia (6.1 hemoglobin) No follow-up attempts possible. Lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: passing away


VAERS ID: 1427514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC889 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; JANUVIA [SITAGLIPTIN]; ROSUVASTATIN; METFORMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021688133

Write-up: Death; Nervous system disorder; Cerebral hemorrhage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB BE-FAMHP-DHH-N2021-95019. A 69-years-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 28May2021 (Lot Number: FC889) as single dose for covid-19 immunisation. Medical history included diabetes. Concomitant medications included insulin glargine (LANTUS); sitagliptin (JANUVIA); rosuvastatin; metformin hydrochloride (METFORMAX). The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date (Lot /batch number unknown) as single dose for covid-19 immunisation. The patient experienced nervous system disorder, death and cerebral hemorrhage on 01Jun2021. The patient died on 03Jun2021. 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: Nervous system disorder; Cerebral hemorrhage; Death


VAERS ID: 1427516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness
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: BEPFIZER INC2021686386

Write-up: got sick; This is a spontaneous report from a contactable consumer (patient''s partner). A female patient of an unspecified age received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) as an unspecified dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got sick after taking BNT162B2 on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: got sick


VAERS ID: 1427554 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cardiac failure congestive, Confusional state, Disease recurrence, Fluid retention, Gait disturbance, General physical health deterioration, Peripheral swelling, Pulmonary oedema, Somnolence
SMQs:, Cardiac failure (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 78
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; METOPROLOL; APIXABAN
Current Illness: Atrial fibrillation; Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Swelling of feet (for few years but they were able to manage it)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021708116

Write-up: more difficulties to walk; confused; Feet swelling; Feet swelling; Lack of balance; sleepier; congestive heart failure; water on his lung and in his body; water on his lung and in his body; his health dropped; This is a spontaneous report from a contactable consumer (patient''s daughter) reporter for her father. A 102-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular, administered in Arm Left on 07Mar2021 16:30 at single dose for COVID-19 immunisation. Medical history included hypertension and atrial fibrillation from 2017 and ongoing, feet swollen for few years but they were able to manage it. Concomitant medications included perindopril taken for hypertension from 2017 and ongoing; metoprolol taken for atrial fibrillation from 2017 and ongoing; apixaban (APIXABAN) taken for an unspecified indication from 2004 and ongoing. The patient experienced feet swelling, lack of balance, sleepier since 14Mar2021, which resulted in death, required emergency room visit. It was reported that the reporter was reporting for his dad who was 102 years old when he received his first Pfizer vaccine on 07Mar2021. A week after receiving the vaccine since 14Mar2021, his feet stated to swollen. This was something he had for few years but they were able to manage it. He was able to walk by himself etc. He lived with his daughter. On the 16Mar2021, she called his doctor to have him checked as he had swollen feet and was furniture surfing as he had like a lack of balance. The doctor said that he will see him 25Mar2021. On 20Mar2021, his father had more and more difficulties to walk and was sleepier and a bit confused too. So reporter called the ambulance. At the hospital, the doctor told reporter his dad as congestive heart failure, he had water on his lung and in his body. He stayed 1 week at the hospital and finally past away on 19May2021. The reporter was under the impression that after the vaccine, his health dropped, and pushed him over the edge. The outcome of the events was fatal. The patient died on 19May2021. It was not reported if an autopsy was performed. Information on the batch number has been requested. ; Reported Cause(s) of Death: water on his lung and in his body; water on his lung and in his body; Feet swelling; Lack of balance; sleepier; difficulties to walk; his health dropped; confused; congestive heart failure


VAERS ID: 1427566 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Erythema, Heart rate, Polymerase chain reaction, Urine analysis, Urosepsis
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: TOREM [TORASEMIDE SODIUM]; HALDOL; ESOMEPRAZOL [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Alcohol abuse; Cardiac failure; Cirrhosis liver (Child B liver cirrhosis on an ethyltoxic basis. Child-Pugh B (9 points)); Dementia (- Dementia based on ethyltoxicity/differential diagnosis (DD) senility); Hepatopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Duodenal ulcer (History of anemic gastrointestinal haemorrhage from duodenal ulcer (Jan2021)); Gastrointestinal haemorrhage (History of anemic gastrointestinal haemorrhage from duodenal ulcer (Jan2021)); Respiratory failure (in the course of anemia on erosive duodenitis)
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Blood pressure; Result Unstructured Data: Test Result:normal mmHg; Test Date: 20210513; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension mmHg; Test Date: 20210514; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/62 mmHg; Test Date: 20210513; Test Name: body temperature; Result Unstructured Data: Test Result:38.6; Comments: fever with shaking chills; Test Date: 20210514; Test Name: HR; Result Unstructured Data: Test Result:78; Comments: bpm; Test Date: 20210513; Test Name: PCR Test on the fingers; Result Unstructured Data: Test Result:123 mg/l; Test Date: 20210513; Test Name: Combur Test; Result Unstructured Data: Test Result:specific gravity 1020, PH 6/7, Leukocytes 2+; Comments: Specific gravity 1020, PH 6/7, Leukocytes 2+, Protein 1+, Erythrocytes 4+
CDC Split Type: CHPFIZER INC2021681227

Write-up: urinary-onset sepsis; Death; itchy erythema abdomen and thighs next day (04May2021); This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number is CH-SM-2021-16428. A 75-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 03May2021 (Batch/Lot number was not reported) (at the age of 75-years-old) as second dose, single for COVID-19 immunisation. Medical history included anemic gastrointestinal haemorrhage from duodenal ulcer from Jan2021 to an unknown date, ongoing Child B liver cirrhosis on an ethyltoxic basis Child-Pugh B (9 points), ongoing dementia based on ethyltoxicity/differential diagnosis (DD) senility, ongoing chronic cardiac failure, had recent episode of severe partial respiratory failure on cardiac failure in the course of anemia on erosive duodenitis on 22Jan2021, ongoing alcohol abuse and ongoing hepatopathy. Concomitant medications included torasemide sodium (TOREM); haloperidol (HALDOL); and esomeprazole magnesium (ESOMEPRAZOL); all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (COMIRNATY) on 03Apr2021 (at the age of 75-years-old) intramuscularly for COVID-19 immunisation with no adverse reactions. After vaccination of the second dose, patient was presented with itchy erythema abdomen and thighs the next day (04May2021), administered steroids and Xyzal with benefit. In the morning of 13May2021, the patient was presented with drowsier with presence of malodorous urine, in the absence of dysuria or other symptomatology. They performed a Combur test which showed: Specific gravity 1020, PH 6/7, Leukocytes 2+, Protein 1+, Erythrocytes 4+. They kept the patient under observation and stimulated him to hydrate. During the afternoon of 13May2021, the patient remained apyretic with normal blood pressure. In the evening of the same day, the patient complained of generalized pain and fever 38.6 with shaking chills, hypotension, they performed PCR test on the finger resulting 123 mg/L. In the suspicion of infection with urinary source on 13May2021 at 22.00, they undertook therapy with Rocephin 2 gr iv and administered effervescent Dafalgan. In history of no known allergy. Throughout the night and the following day (14May2021), the patient remained apyretic. In the evening of 14May2021, fever recurred after administration of Dafalgan (antibiotic therapy already administered), blood pressure at 20:21 equal to 112/62 mmHg with HR 78 bpm. At 03:00 in the morning day 15May2021, during the night nursing rounds, the patient was found in bed lifeless. Given the clinic, it is possible that the urinary-onset infection caused a septic state despite broad-spectrum antibiotic therapy. No other diagnostic tests were done. The most likely hypothesis of death is urinary-onset sepsis. Death was COMPLETELY unexpected as a frail patient suffering from Hepatopathy on ethyl basis: - Child -Pugh B (9 points) (22Jan2021), recent (22Jan2021) episode of severe partial respiratory failure on cardiac failure in the course of anemia on erosive duodenitis, cognitive decline of mixed origin. Patient was hospitalized due to urinary-onset sepsis on 13may2021. Outcome of erythema was recovered in May2021 while urinary-onset sepsis was fatal. The patient died on 15May2021. No autopsy was performed. This case was reported as serious with seriousness criterion results in death. A causality between Comirnaty and death was assessed as being unlikely, and between Comirnaty and erythema as possible. Sender''s comment (Swissmedic): Death occurred 10 days after the second dose of vaccine with onset of fever, positive Combur test, elevated PCR in a frail patient (death reported by the physician as not completely unexpected) with suspicion of sepsis with urinary origin. Despite the absence of autopsy but given the clinical (fever and elevated PCR, positive Combur test) and the suspicion of urinary sepsis we judged as unlikely the causality between death and the vaccine. Regarding the causal correlation with erythema, given the close causal relationship and the notoriety of the reaction we judged the causal correlation as possible. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender''s Comments: There is no reasonable possibility that event death is related to BNT162B2. The event death is likely an intercurrent condition.; Reported Cause(s) of Death: urinary-onset sepsis; death


VAERS ID: 1427587 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Diarrhoea, Pneumonia, SARS-CoV-2 test, Vaccination site pain
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), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 14
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: Blindness; Hypercholesteremia; Hypertension; Incontinent; Knee arthritis (Bilateral, grade III.-IV.)
Preexisting Conditions: Medical History/Concurrent Conditions: Breast carcinoma (Chemotherapy succesfully ended on Jan2020); COVID-19 (The patient was hospitalised.)
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20210226; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC2021682032

Write-up: Diarrhea; cardiac arrest; Pneumonia; Injection site pain; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB CZ-CZSUKL-21006532. A 69-years-old female patient received 1st dose of bnt162b2 (COMIRNATY), at the age of 69-years-old intramuscular on 26Apr2021 (Lot Number: EX0893) as dose 1, single for covid-19 immunisation. Medical history included breast cancer from an unknown date to Jan2020 (Chemotherapy succesfully ended on Jan2020), ongoing arthritis Bilateral, grade III.-IV , ongoing incontinence , ongoing hypercholesterolaemia , ongoing blindness , ongoing hypertension , covid-19 from 25Feb2021 (patient was hospitalized). The patient''s concomitant medications were not reported. The patient was hospitalised on 25Feb2021 because of COVID-19, it was confirmed by PCR on 26Feb. She was tired, malaise, had fevers of 38,8C. On 05Mar2021 she was discharged, she was still weak and tired but otherwise without problems. Approximately after a week her physical and mental condition returned to the pre-COVID-19 state. On her own request she was vaccinated on 26Apr2021 in a vaccination centre. After the vaccination her arm hurt at the injection site, she iced the area, but it was without oedema or change of colour. 05May2021 the patient started experiencing loose stools of an unknown origin. 07May2021 she took Imodium, 08May2021 she was without problems, in the evening she had desserts and open sandwiches. 09May2021 constant diarrhea up until the emergency services arrived (at 16:30 after taking Imodium four times and two activated charcoal times). The patient was hospitalised in the intensive care unit in the internal department, her condition was stabilised. 10May2021 in the morning her condition deteriorated, the patient had pneumonia, she was put on oxygentherapy, the patient was transported to the anesthesiology, resuscitation and intesive care unit. The patient had a cardiac arrest, she was resuscitated after 14 minutes. Multiple inflammation sites were found in the abdomen cavity affecting all the internal organs. On 10May2021 after 15:30 the reporter was contacted that the patient had another cardiac arrest and died. Autopsy was not performed. The patient underwent lab tests and procedures which included body temperature: 38.8 centigrade on 26Feb2021, sars-cov-2 test: positive on 26Feb2021. The outcome of Cardiac arrest was fatal, of other events was unknown. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1427591 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210638397

Write-up: This spontaneous report received from a patient concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died and cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1427594 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Paraneoplastic thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic lymphocytic leukaemia; Hypertension; Hypopharyngeal cancer (Metastatic hypopharyngeal carcinoma)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021681960

Write-up: Unknown cause of death; Paraneoplastic pulmonary embolism suspected; Paraneoplastic pulmonary embolism suspected; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100091176. A 66-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration, at age 66 years, on 26May2021 (Batch/Lot Number: 1D012A) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Ongoing medical history included metastatic hypopharyngeal carcinoma, chronic lymphocytic leukaemia and hypertension. The patient''s concomitant medications were not reported. On 27May2021, the patient experienced unknown cause of death, suspected (susp.) paraneoplastic pulmonary embolism. Patient died in inpatient oncological therapy. The patient died on 27May2021. It was not reported if an autopsy was performed. This report is serious - death. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death; Paraneoplastic pulmonary embolism suspected


VAERS ID: 1427595 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-30
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

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: Arterial hypertension; Hypercholesteremia; Triple vessel disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021681947

Write-up: Ventricular fibrillation; Acute myocardial infarction; This is a spontaneous report downloaded from the Regulatory Authority-WEB. Regulatory Authority number DE-PEI-202100091178. A non-contactable physician reported that a 62-year-old male patient received bnt162b2 (COMIRNATY, lot number: EX7823, expiry date unknown), via an unspecified route of administration on 18May2021, as an unknown dose number, 0.3ML single for COVID-19 immunization. Medical history included arterial hypertension, hypercholesteremia and triple vessel disease all ongoing. The patient''s concomitant medications were not reported. The patient experienced ventricular fibrillation and acute myocardial infarction on 30May2021. Resuscitation was performed on the patient. The patient died on 30May2021 due to the events ventricular fibrillation and acute myocardial infarction. It was not reported if an autopsy was performed. Event assessment for Comirnaty with all events (source of assessment: Regulatory Authority) was unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction; Ventricular fibrillation


VAERS ID: 1427597 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: Obduktionsergebnis nicht bekannt
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021681989

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB number DE-PEI-202100092190. An 84-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 18May2021 (Lot Number: 1C007A) at the age of 84-years-old as dose 1, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 20May2021, the patient experienced sudden death unexplained. The event was reported as serious due to death. The outcome of the event was fatal. The patient died on 20May2021. An autopsy was performed, and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1427598 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Inappropriate schedule of product administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Coronary disease; Smoker (30 cig / d)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial bypass operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021681966

Write-up: Unknown cause of death; General debility; Pyrexia; first dose of bnt162b2 (COMIRNATY), on 21Apr2021/ second dose on 02Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (regulatory authority number: DE-PEI-202100092201). A 77-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 ml, lot number and expiry date were not reported), via an unspecified route of administration on 02Jun2021 (received at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD), arterial bypass operation from an unknown date and unknown if ongoing, ongoing coronary artery disease, ongoing smoker 30 cig / d. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY), on 21Apr2021 (Batch/Lot Number: Unknown) for COVID-19 immunszation. The patient experienced general debility and pyrexia on 04Jun2021, and unknown cause of death on 05Jun2021. The adverse events resulted into death. The patient died on 05Jun2021. 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: general debility; pyrexia; Unknown cause of death


VAERS ID: 1427601 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-05-13
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021681982

Write-up: Sudden cardiac death; Ventricular fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100092243. A 58-year-old male patient received his dose of BNT162B2 (COMIRNATY; strength: 0.3 mL; lot number: EX8679), via an unspecified route of administration on 01Jan2021 (pending clarification, reported as 01Jan2020) at the age of 57-years old (reported as 56-years-old) at dose number unknown, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13May2021, the patient died due to resuscitation, sudden cardiac death, and ventricular fibrillation. The patient did not undergo autopsy. Outcome of all the events was fatal. The relatedness of the drug to all the events was unclassifiable.; Reported Cause(s) of Death: resuscitation; Ventricular fibrillation; Sudden cardiac death


VAERS ID: 1427602 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Emphysema pulmonary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021687971

Write-up: Deep vein thrombosis; Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100092392. A 78-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 27May2021 (at age of 78 years old, Lot Number: 1D012A) as a single dose for covid-19 immunization. Medical history included ongoing emphysema pulmonary. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) on 15Apr2021 as 0.3 ml single (batch unknown) for covid-19 immunization. The patient experienced deep vein thrombosis and pulmonary embolus on an unspecified date. The events were assessed as serious (death). The outcome of the events was fatal. The patient died on 28May2021. An autopsy was performed that revealed pulmonary embolism (pulmonary embolism). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolus; Deep vein thrombosis; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1427603 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-06-01
   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: Arterial hypertension; Arterial occlusive disease; Gout; Lipid metabolism disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021687955

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100092403. A 70-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot Number unknown), at the age of 70-years-old, as single dose for COVID-19 immunisation. Medical history included ongoing arterial hypertension, ongoing gout, ongoing lipid metabolism disorder NOS, ongoing arterial occlusive disease. The patient previously received first dose of Comirnaty (batch unknown, 0.3 ml) on 28Apr2021 for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced sudden death unexplained on 01Jun2021. The patient died on 01Jun2021. It was not reported if an autopsy was performed. The patient''s outcome was fatal for sudden death unexplained. The event assessment with Comirnaty was unclassifiable. Reporter comment: The wife reported that especially after the 2nd vaccination on 19May2021, until the sudden event on 01Jun2021, there were no abnormalities in terms of vaccination complications or side effects. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: The wife reported that, especially after the 2nd vaccination on 19May2021, until the sudden event on 01Jun2021, there were no abnormalities in terms of vaccination complications or side effects.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1427604 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, General physical health deterioration, Left atrial enlargement, Pulmonary embolism, Vena cava thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), 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: Obesity (BMI 41)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain lower; Deep venous thrombosis arm
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021688329

Write-up: Lung embolism; General physical condition decreased; Fulminant LAE, already adhering to the wall on the right, rinsable on the left; Thrombus remnants in the V. cava inf. and the deep veins of the right US.; Thrombus remnants in the V. cava inf. and the deep veins of the right US.; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, company number DE-PEI-202100092407. A 32-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) at the age of 32-year-old, as dose number unknown, single for covid-19 immunisation. Medical history included deep vein thrombosis from 2021, abdominal pain lower, ongoing obesity (BMI 41). The patient''s concomitant medications were not reported. The patient experienced general physical condition decreased and lung embolism on an unspecified date. The events outcome was fatal. The patient died on an unspecified date. An autopsy was performed that revealed Fulminant LAE, already adhering to the wall on the right, rinsable on the left; Thrombus remnants in the V. cava inf. and the deep veins of the right US. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Lung embolism; General physical condition decreased; Autopsy-determined Cause(s) of Death: Fulminant LAE, already adhering to the wall on the right, rinsable on the left; Thrombus remnants in the V. cava inf. and the deep veins of the right US.


VAERS ID: 1427622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diabetes mellitus management, Hypoglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (emergency doctor called-unfortunately doctor could not help in the end.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Blood sugar; Result Unstructured Data: Test Result:massive hypoglycaemia
CDC Split Type: DEPFIZER INC2021688020

Write-up: Ultimately, patient died of massive hypoglycaemia. Two days after she was vaccinated; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021087385. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100080231. A 79-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included ongoing Chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. This report is serious-death. Ultimately, patient died of massive hypoglycaemia. Two days after she was vaccinated (On 12Apr2021). The patient''s outcome was fatal. The patient died on 12Apr2021. An autopsy was not performed. Sender Comment: Information on risk factors or previous illnesses. Chronic obstructive pulmonary disease-otherwise healthy/emergency doctor called-unfortunately doctor could not help in the end. Comirnaty/ massive hypoglycaemia/Regulatory Authority/Inconsistent causal association to immunization No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: massive hypoglycaemia


VAERS ID: 1427623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: COVID-19 (She even had a Covid contact (other country mutation) with no symptoms or problems.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021687984

Write-up: Three days after the vaccination, she had minor strokes from which my mother died.; This is a spontaneous report from a non-contactable consumer (patient''s children) downloaded from the regulatory authority-WEB. The regulatory authority report number is [DE-PEI-CADR2021087777] and Safety Report Unique Identifier [DE-PEI-202100080381]. A 93-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included covid-19 (She even had a Covid contact (other country mutation) with no symptoms or problems). The patient''s concomitant medications were not reported. Three days after the vaccination on 19Apr2021, patient had minor strokes from which and she died. The patient died on 20May2021. The outcome of the event was fatal. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cerebrovascular accident NOS


VAERS ID: 1427624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT angiography; Result Unstructured Data: Test Result:basilar artery and bilateral vertebral artery; Comments: basilar artery and bilateral vertebral artery occlusion
CDC Split Type: DEPFIZER INC2021682047

Write-up: Cryptogenic stroke with basilar thrombosis; Cryptogenic stroke with basilar thrombosis; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB [Regulatory authority number DE-PEI-CADR2021087855]. A 55-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 mL, single for COVID-19 immunization. Medical history included arterial hypertension (unknown if ongoing). Concomitant medications were not reported. On 22May2021, the patient stroke symptoms with dizziness and unsteady gait. In the course of severe brainstem symptoms the patient had CT angiography which indicated the basilar artery and bilateral vertebral artery occlusion. It was later reported that the patient had cryptogenic stroke with basilar thrombosis with inefficient attempted thrombectomy. No major atherosclerosis was noted. The patient died in 2021 due to cryptogenic stroke with basilar thrombosis. It was unknown if autopsy was performed. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) Basilar artery thrombosis and Accident cerebrovascular was unclassifiable. Health Authority Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: Arterial hypertension. From 22May2021 stroke symptoms with dizziness, unsteady gait. In the course of severe brainstem symptoms. In the CT angiography, the basilar artery and bilateral vertebral artery occlusion were demonstrated. Inefficient attempted thrombectomy. No major atherosclerosis. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cryptogenic stroke with basilar thrombosis; Cryptogenic stroke with basilar thrombosis


VAERS ID: 1427625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cough, Death, Dyspnoea, Heart rate, Oxygen saturation, Oxygen saturation decreased, Peripheral swelling, Pulmonary congestion, Vital signs measurement
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Heart insufficiency (cardiac insufficiency); Hypertensive heart disease; Type 1 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: blood pressure; Result Unstructured Data: Test Result:stable; Test Date: 20210525; Test Name: pulse; Result Unstructured Data: Test Result:stable; Test Date: 20210522; Test Name: O2 saturation; Result Unstructured Data: Test Result:low; Test Date: 20210525; Test Name: O2 saturation; Result Unstructured Data: Test Result:stable; Comments: under room air; Test Date: 20210525; Test Name: vital parameters; Result Unstructured Data: Test Result:stable; Comments: pulse, blood pressure , O2 saturation under room air
CDC Split Type: DEPFIZER INC2021688015

Write-up: died; pulmonary congestion; Oxygen saturation low; Cough; swelling of legs/slight leg edema; dyspnoea/shortness of breath; This is a spontaneous report downloaded from a non-contactable consumer via the Regulatory Authority-WEB. Regulatory Authority number DE-PEI-CADR2021087920, Safety Report Unique Identifier DE-PEI-202100080566. A 86-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 11May2021 (Lot Number: EX8680) as 0.3ml single dose for covid-19 immunisation. Medical history included Arterial hypertension, Hypertensive heart disease, Heart insufficiency (cardiac insufficiency), Type 1 diabetes mellitus, all ongoing. The patient''s concomitant medications were not reported. The patient experienced dyspnoea, cough, swelling of legs, oxygen saturation low since 22May2021. The patient''s outcome was fatal for death, not recovered/not resolved for other events. The patient died on 25May2021. An autopsy was not performed. Sender Comment: The patient had no known allergies. Information on risk factors or previous illnesses included arterial hypertension, hypertensive heart disease with cardiac insufficiency, diabetes mellitus type 1. Beginning with a clear cough from 22May2021 and subsequent increasing shortness of breath, for a home visit on 25May2021, rest dyspnoea, slight leg edema, pulmonary congestion, no fever, stable vital parameters (pulse, blood pressure, O2 saturation under room air). Event assessment for Comirnaty for all events per Regulatory Authority was Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: died


VAERS ID: 1427626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Circulatory collapse, Computerised tomogram, Nausea, Peripheral vascular disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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: Chronic kidney disease; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Chills; Cough; Fever
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC2021688003

Write-up: stroke; Nausea; Circulatory disorder peripheral; Vomiting; circulatory collapse; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021088025, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100080890. This is a first of two reports for the second dose. A 85 Years old male patient received second dose BNT162B2 (COMIRNATY, lot number EW8904), via an unspecified route of administration on 13-APR-2021 at single dose for COVID-19 immunisation. The medical history included ongoing Hypertension, ongoing Chronic kidney disease and high fever, chills, cough. The concomitant medications were not reported. The Historical Vaccine was COMIRNATY (Strength: 0.3 ml) on 23FEB2021 for Prophylactic vaccination and experienced Pneumonia. On 01May2021 the patient experienced Vomiting, Nausea, Circulatory disorder peripheral, stroke, circulatory collapse. The patient was hospitalized due to all of the events in 2021. The patient underwent lab tests and procedures, which included CT : unknown result. The patient died on an unknown date. It''s unknown if an autopsy was performed. The cause of death was stroke. The outcome of the event stroke was fatal, the others was not recovered. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021696465 same patient and drug, different dose/event; Reported Cause(s) of Death: stroke


VAERS ID: 1427627 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: Aortic valve stenosis; Arterial hypertension; Coronary heart disease; Heart valvular prosthesis wearer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021688009

Write-up: This is a spontaneous report from a non-contactable consumer. A 79-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: 1C007A), via an unspecified route of administration on 18May2021 (at age of 79 years old) as 0.3 ml single dose for COVID-19 immunisation. Medical history included ongoing Coronary heart disease, Aortic valve stenosis, Heart valvular prosthesis wearer, Arterial hypertension. The patient''s concomitant medications were not reported. The Patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection), on 15Apr2021 (Batch Number: ET30345) at 79 years old as 0.3 ml single for COVID-19 immunisation, well tolerated. On 19May2021 the patient experienced Fatigue, Unknown cause of death. This report is serious-death. The patient''s outcome was: not recovered for Fatigue, fatal for Unknown cause of death. The patient died on 20May2021. An autopsy was not performed. Sender Comment: Information on risk factors or previous illnesses, coronary artery disease, aortic valve stenosis, heart valve prosthesis, art. Hypertension. 1st vaccination Comirnaty 15Apr2021 ET30345 well tolerated. one day after the vaccination tired and exhausted, died on the night of 20May2021. Cause of death unclear, death probably due to previous illnesses. Event assessment: Comirnaty/event/PEI /Result of Assessment: C. Inconsistent causal association to immunization No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1427628 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
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: 2021-04-21
   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: Dependence on renal dialysis; Heart disorder; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021688347

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021089821. A 65-years-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as 0.3 ML single dose for COVID-19 immunisation. Medical history included ongoing Renal insufficiency, ongoing Dependence on renal dialysis, ongoing Heart disorder. The patient''s concomitant medications were not reported. On 21Apr2021 the patient experienced Unknown cause of death. It was not reported if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses, Dialysis patient, kidney failure, weak heart. Event assessment: Comirnaty/event/Regulatory Authority/Result of Assessment: Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1427632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021687936

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the a regulatory authority-WEB DCGMA number DE-PEI-CADR2021090380, Safety Report Unique Identifier DE-PEI-202100083500. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number unknown), at 0.3 ml, single dose for COVID-19 immunisation. Medical history included ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. On 28May2021, the patient experienced unknown cause of death. It was unknown if an autopsy was performed. This report is serious-death. The outcome of the event was fatal. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no / possibly sudden cardiac death with known type 2 diabetes with multiple complications. Event assessment : Comirnaty/event/PEI /Result of Assessment: C. Inconsistent causal association to immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1427634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-23
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Aortic aneurysm rupture, Back pain, Loss of consciousness, Shock haemorrhagic, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Retroperitoneal fibrosis (broad), Hypovolaemic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: Accident cerebrovascular (3 strokes in the past ); Smoker; Tethered cord syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021687947

Write-up: Bleeding shock; Collapse; pain in the abdomen; loss of consciousness; Burst abdominal aortic aneurysm shortly after the 2nd vaccination with Biontech; stabbing pain in the stomach; Severe back pain; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021092168, Safety Report Unique Identifier DE-PEI-202100085377. A 71-year-old male patient received bnt162b2 (COMIRNATY, strength:0.3 ml), dose 2 via an unspecified route of administration on 14May2021 (Lot Number EX8680), at single dose for COVID-19 immunisation. Medical history included Tethered cord syndrome, Accident cerebrovascular(3 strokes in the past), Smoker, all ongoing. The patient previously took first dose of bnt162b2(COMIRNATY), on 14Apr2021 (strength:0.3 ml) for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 23May2021, the patient experienced abdominal aortic aneurysm hemorrhage and burst abdominal aortic aneurysm shortly after the 2nd vaccination with Biontech. On 23May2021 for the first time stabbing pain in the stomach, which has subsided again. Severe back pain. On 26May2021 Collapse after pain in the abdomen, loss of consciousness, resuscitation and admission to the hospital. Diagnosis: ruptured abdominal aortic anheurysm. Operation using a tube prosthesis. Bleeding shock too strong, despite strong circulatory stabilizing drugs and 20 blood reserves, no improvement in condition. Died on 27May2021 in the morning. An autopsy was not performed. This report is serious - death, hospitalization. The outcome of the event "Burst abdominal aortic aneurysm shortly after the 2nd vaccination with Biontech" was fatal, of the event "stabbing pain in the stomach" was recovered, of the other events was unknown. Event assessment: Comirnaty/ Abdominal aortic aneurysm hemorrhage/Regulatory Authority/Inconsistent causal association to immunization Sender Comment: Do you or the person concerned have any known allergies? If so, which ones?No Information on risk factors or previous illnesses: Tethered Cord Syndrome, 3 strokes in the past, Smoker On 23May2021 for the first time stabbing pain in the stomach, which has subsided again. Severe back pain. On 26May2021 Collapse after pain in the abdomen, loss of consciousness, resuscitation and admission to the hospital. Diagnosis: ruptured abdominal aortic anheurysm. Operation using a tube prosthesis. Bleeding shock too strong, despite strong circulatory stabilizing drugs and 20 blood reserves, no improvement in condition. Died on 27May2021 in the morning. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Abdominal aortic aneurysm hemorrhage


VAERS ID: 1427637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 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: Iodine allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021682060

Write-up: My mother died ten days after the 2nd vaccination with Biontech; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, company number DE-PEI-CADR2021093355. A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: EP9598) as dose 2, single for covid-19 immunisation. Medical history included iodine allergy. The patient had no previous illnesses. The patient had no concomitant medications. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter''s mother died ten days after the 2nd vaccination with bnt162b2. It was reported that the mother probably died of heart failure during her afternoon nap, heart attack, or cardiac arrest. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: My mother died ten days after the 2nd vaccination with Biontech


VAERS ID: 1427638 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Arteriosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210638122

Write-up: DEATH TEMPORALLY RELATED TO COVID-19 VACCINATION (1 DAY INTERVAL BETWEEN VACCINATION AND DEATH) CAUSE OF DEATH: RUPTURED MYOCARDIAL INFARCTION IN CORONARY THROMBOSIS; DEATH TEMPORALLY RELATED TO COVID-19 VACCINATION (1 DAY INTERVAL BETWEEN VACCINATION AND DEATH) CAUSE OF DEATH: RUPTURED MYOCARDIAL INFARCTION IN CORONARY THROMBOSIS; HEADACHES; This spontaneous report received from a consumer via a Regulatory Authority, DE-PEI-CADR2021099560] concerned a 64-year-old male patient of unspecified race and ethnic origin. The patient''s weight was 98 kilograms, and height was 176 centimeters. The patient''s concurrent condition included arteriosclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 22-MAY-2021, the patient experienced headaches. On 23-MAY-2021, the patient died from ruptured myocardial infarction and coronary thrombosis which was determined by an autopsy (date unspecified). It was reported that the patient''s death was temporally related to covid-19 vaccination (1 day interval between vaccination and death). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. An autopsy was performed on an unspecified date. The patient died of death temporally related to covid-19 vaccination (1 day interval between vaccination and death) cause of death: ruptured myocardial infarction in coronary thrombosis, and headaches on 23-MAY-2021. This report was serious (Death).; Sender''s Comments: V0;20210638122- covid-19 vaccine ad26.cov2.s-death temporally related to covid-19 vaccination (1 day interval between vaccination and death) cause of death: ruptured myocardial infarction in coronary thrombosis, headaches . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CORONARY THROMBOSIS; INFARCT MYOCARDIAL; HEADACHE; Autopsy-determined Cause(s) of Death: CORONARY THROMBOSIS; INFARCT MYOCARDIAL; HEADACHE


VAERS ID: 1428121 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021695729

Write-up: This is a spontaneous report based on information received by Pfizer from BioNTech license party for BNT162B2 (COMIRNATY). A patient of an unspecified age and gender received BNT162B2 (COMIRNATY) via an unspecified route of administration as a single dose on an unspecified date (Batch number not known) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The contactable physician reported that a patient has suffered cardiac death in relationship with the COMIRNATY vaccination. This case has already been reported by the relevant clinic (clinic unknown). It is not yet known whether there is a relationship with the vaccination. At the beginning of the conversation, the physician mentioned "myocarditis", but it is unknown whether the patient suffered from it before or after the vaccination." It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on narrative given in the case there is reasonable possibility of causal association between the events Cardiac Death, Myocarditis and the suspect product Comirnaty. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac death; Myocarditis


VAERS ID: 1428138 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
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: DEPFIZER INC2021750946

Write-up: Death; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 66739], license party for Comirnaty. An unspecified age male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 17Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient experienced death on an unknown date. Reported as: The patient dead after the first vaccination with COMIRNATY. The outcome of event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the limited information in the case report a meaningful assessment of a causal relationship is not possible. The case will be reassessed once additional information will be 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: 1428156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Base excess, Blood bicarbonate, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, COVID-19, Cerebral haemorrhage, Chest X-ray, Computerised tomogram head, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin level, Red blood cell count, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: ATORVASTATIN; OMEPRAZOLE; NOBRITOL; SERTRALINE; PARACETAMOL; VALSARTAN; ORFIDAL; HIDROFEROL; NATECAL D; CONDROSULF; ADIRO; BRILIQUE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Dyslipidemia; Exertional dyspnea; Hypertension arterial; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: aptt; Test Result: 25.9 s; Test Date: 20210524; Test Name: aptt; Test Result: 25.3 s; Test Date: 20210515; Test Name: coronary CT scan; Result Unstructured Data: Test Result:Coronary angiography was performed with 64-slice C; Comments: Coronary angiography was performed with 64-slice CT and a low-dose technique, after previous administration of intravenous contrast of high radiological density (Iomeron 400), with electrocardiographic control. A CD is supplied with the axial images and 3D reconstructions, as well as photographic recordings of the coronary analysis. Coronary dominance: right. LMCA: normal origin from the left sinus of Valsalva, without plaques or stenosis. LAD: diffuse calcified atheroma plaques that at some point could lead to significant stenosis. It gives a first diagonal of small caliber and second diagonal of greater caliber with calcified atheroma plaques. LCX: eccentric calcified plaques that do not condition significant stenosis. It gives a well-developed marginal obtuse, without significant lesions. RCA: normal origin of the right sinus of Valsalva, with isolated calcified plaques that do not condition stenosis along its course.; Test Date: 20210522; Test Name: base excess; Result Unstructured Data: Test Result:1.1 mEq/l; Test Date: 20210524; Test Name: base excess; Result Unstructured Data: Test Result:1 mEq/l; Test Date: 20210522; Test Name: hco3; Result Unstructured Data: Test Result:22.4 mEq/l; Test Date: 20210524; Test Name: hco3; Result Unstructured Data: Test Result:25.2 mEq/l; Test Date: 20210522; Test Name: chloride; Result Unstructured Data: Test Result:109 mEq/l; Test Date: 20210524; Test Name: chloride; Result Unstructured Data: Test Result:111 mEq/l; Test Date: 20210522; Test Name: CPK; Result Unstructured Data: Test Result:83; Test Date: 20210524; Test Name: CPK; Result Unstructured Data: Test Result:83; Test Date: 20210522; Test Name: creatinine; Result Unstructured Data: Test Result:0.53; Comments: mg%; Test Date: 20210524; Test Name: creatinine; Result Unstructured Data: Test Result:0.45; Comments: mg%; Test Date: 20210522; Test Name: fibrinogen; Result Unstructured Data: Test Result:584; Comments: mg%; Test Date: 20210524; Test Name: fibrinogen; Result Unstructured Data: Test Result:697; Comments: mg%; Test Date: 20210522; Test Name: glucose; Result Unstructured Data: Test Result:174; Comments: mg%; Test Date: 20210524; Test Name: glucose; Result Unstructured Data: Test Result:195; Comments: mg%; Test Date: 20210522; Test Name: lactic acid; Result Unstructured Data: Test Result:1.4 mEq/l; Test Date: 20210524; Test Name: lactic acid; Result Unstructured Data: Test Result:1.2 mEq/l; Test Date: 20210522; Test Name: potassium; Result Unstructured Data: Test Result:3.93 mEq/l; Test Date: 20210524; Test Name: potassium; Result Unstructured Data: Test Result:4.13 mEq/l; Test Name: blood pressure; Result Unstructured Data: Test Result:140/70 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:88/56 mmHg; Comments: (67); Test Date: 20210522; Test Name: sodium; Result Unstructured Data: Test Result:138 mEq/l; Test Date: 20210524; Test Name: sodium; Result Unstructured Data: Test Result:141 mEq/l; Test Date: 20210522; Test Name: urea; Test Result: 30 mg/dl; Test Date: 20210524; Test Name: urea; Test Result: 44 mg/dl; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:no parenchymal infiltrates, no signs of fluid over; Comments: no parenchymal infiltrates, no signs of fluid overload, no cardiomegaly, TOT, normalized CVCs; Test Date: 20210521; Test Name: head CT; Result Unstructured Data: Test Result:Large acute left frontal intraparenchymal hematoma; Comments: Large acute left frontal intraparenchymal hematoma that generates a large mass effect with signs of subfacial and slight descending transtentorial herniation, and with intraventricular hemorrhage. Acute subdural hematoma throughout the entire extension of the falx cerebri to the left tentorium. Basal CT of the skull was performed and the study was completed with administration of VSD. A large left frontal intraparenchymal hematoma with dimensions 7.4 x 6.3 x 5.1 cm (AP x T x CC) and an approximate volume of 167cc is identified, which associates a hypodense halo in relation to moderate vasogenic edema. It generates a large mass effect in the adjacent parenchyma with obliteration of the sulci and the ipsilateral ventricular system, and deviation of the midline structures to the right of up to approximately 1.5 cm with signs of subfalcial herniation. A slight asymmetry of the perimesencephalic cisterns is also observed, suggesting some degree of descending transtentorial herniation. The hematoma is open to the ventricles with a small amount of blood in the frontal horn, the foramen of Monro and the third ventricle. Likewise, a small amount of hemorrhagic content may also exist in the fourth ventricle. An extensive subdural hematoma component is also observed in the interhemispheric fissure with a maximum thickness of up to approximately 0.6 cm.; Test Date: 20210522; Test Name: head CT; Result Unstructured Data: Test Result:Radiological diagnosis: Increase in the size of th; Comments: Radiological diagnosis: Increase in the size of the acute left supratentorial intraparenchymal hemorrhage, of the acute subdural hematoma as well as the volume and hemorrhage of the ventricular system. New-onset intra-axial pneumocephalus and subarachnoid hemorrhage foci (see comment). Radiological comment: Basal skull CT is performed. It is compared with a CT of the skull yesterday, 21May. Postoperative changes of decompressive left frontoparietal craniotomy and extra-axial drainage. Compared with the CT scan of 21May2021, the acute intraparenchymal hematoma has increased in size and is now also in the left parietal (post-central) location. Increased volume and intraventricular hemorrhage. New-onset intra-parenchymal and intraventricular intra-axial pneumocephalus. There are foci of subarachnoid hemorrhage in the left Sylvian fissure and in the new-onset right parietal convex sulci. Increase in size of the acute hematoma of the falx cerebri, which in this study measured about 8 mm (in the May 21 study it was about 5 mm). Acute hematoma on the tentorium. The subfacial herniation to the right has decreased and in this study it measures about 5 mm (it measured about 14 mm on the CT of 21May2021). Obliteration of the cistern ambiens persists, probably related to a certain degree of descending transtentorial herniation. Catheter with right front entry probably related to intracranial pressure monitoring device. Tube in right nostril.; Test Date: 20210522; Test Name: hematocrit; Test Result: 30 %; Test Date: 20210524; Test Name: hematocrit; Test Result: 23.8 %; Test Date: 20210522; Test Name: hemoglobin; Result Unstructured Data: Test Result:9; Comments: gr%; Test Date: 20210524; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.9; Comments: gr%; Test Name: heart rate; Result Unstructured Data: Test Result:80; Comments: bpm; Test Name: heart rate; Result Unstructured Data: Test Result:66; Comments: bpm; Test Date: 20210522; Test Name: INR; Result Unstructured Data: Test Result:0.95; Test Date: 20210524; Test Name: INR; Result Unstructured Data: Test Result:0.92; Test Name: o2; Test Result: 95 %; Test Name: o2; Test Result: 96 %; Test Date: 20210522; Test Name: o2 saturation; Test Result: 99.6 %; Test Date: 20210524; Test Name: o2 saturation; Test Result: 98.1 %; Test Date: 20210522; Test Name: pCo2; Result Unstructured Data: Test Result:32 mmHg; Test Date: 20210524; Test Name: pCo2; Result Unstructured Data: Test Result:38 mmHg; Test Date: 20210522; Test Name: pH; Result Unstructured Data: Test Result:7.45; Test Date: 20210524; Test Name: pH; Result Unstructured Data: Test Result:7.43; Test Date: 20210522; Test Name: platelet count; Result Unstructured Data: Test Result:248 x10 3/mm3; Test Date: 20210524; Test Name: platelet count; Result Unstructured Data: Test Result:233 x10 3/mm3; Test Date: 20210522; Test Name: po2; Result Unstructured Data: Test Result:131 mmHg; Test Date: 20210524; Test Name: po2; Result Unstructured Data: Test Result:96 mmHg; Test Date: 20210522; Test Name: prothrombin activity; Test Result: 110 %; Test Date: 20210524; Test Name: prothrombin activity; Test Result: 115 %; Test Date: 20210522; Test Name: rbc; Result Unstructured Data: Test Result:3; Test Date: 20210524; Test Name: rbc; Result Unstructured Data: Test Result:2.67; Test Name: respiratory rate; Result Unstructured Data: Test Result:27; Comments: RPM; Test Date: 20210525; Test Name: PCR SARS-Cov-2; Test Result: Positive ; Test Date: 20210522; Test Name: leukocytes; Result Unstructured Data: Test Result:18.4 x10 3/mm3; Test Date: 20210524; Test Name: leukocytes; Result Unstructured Data: Test Result:20.9 x10 3/mm3
CDC Split Type: ESPFIZER INC2021699239

Write-up: This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 10May2021 (lot number: EX8679) at single dose, and the first dose intramuscularly on 16Apr2021 (lot number: EW4815) at single dose for COVID-19 immunisation, acetylsalicylic acid (ADIRO), via an unspecified route of administration from 2016 and ongoing at 100 mg once a day (0-1-0) for an unspecified indication, and ticagrelor (BRILIQUE), orally from 14May2021 and ongoing at 90 mg twice a day for angioplasty. Medical history included hypertension arterial, dyslipidaemia, angioplasty (elective angioplasty with vasoactive stent 2 weeks ago in the LAD (80% closure). Currently double antiaggregated), ischemic heart disease, and exertional dyspnea. Concomitant medications included atorvastatin for dyslipidaemia, omeprazole, amitriptyline hydrochloride/medazepam (NOBRITOL), sertraline, paracetamol, valsartan, lorazepam (ORFIDAL), calcifediol (HIDROFEROL), calcium carbonate/colecalciferol (NATECAL D), and chondroitin sulfate sodium (CONDROSULF). The patient previously took metoprolol tartrate (BELOKEN) 100 mg orally and 10 mg IV, and sublingual nitroglycerin. The patient experienced cerebral haemorrhage on 21May2021, vaccination failure on 25May2021, and sars-cov-2 test positive on 25May2021. The patient was hospitalized for cerebral haemorrhage from 21May2021. Coronary CT scan of 15Apr2021: Coronary angiography was performed with 64-slice CT and a low-dose technique. Patient with hypertension, DL and FA of ischemic heart disease. Exertional dyspnea. The total radiological dose received was DLP 309.7 mGy/cm. The coronary calcium assessment had a score of 640, which corresponded to a 90 percentile. Coronary angiography: Coronary dominance: right. Angioplasty is performed with an active drug stent implantation in the anterior descending region. Distally it reaches the cardiac cross and gives the posterior descending and posterolateral branches of good development. Other findings: Dilation of the ascending aorta with a maximum transverse diameter of 43 mm. Conclusion: Diffuse calcified atheroma plaques in the LAD, second diagonal and circumflex that at some point in the LAD could lead to significant stenosis. Reason of Admission: Low level of consciousness secondary to left lobar frontal intraparenchymal hematoma open to ventricles with displacement of the midline and surgically drained transtentorial herniation 24 hours ago. Patient beg TAC control. Current illness: Patient brought as a stroke code for presenting right hemiparesis and sudden onset language alteration around 10:00 on 21May2021. She is seen by the Neurology Service at around 11:30, and in the initial examination, spontaneous ocular opening, aphasia without obeying orders, gaze deviation and facial ismetry that she does not correct are observed. As for the motor, she presents Right Lower Limb plegia, moving the Left Lower Limb on plan. She scores on the NIHSS 23 (1 consciousness, 2 questions, 2 commands, 1 Horizontal extraocular movements, 2 visual fields, 2 facial, 4 Motor Arm, 3 Motor Leg, 1 sensitive, 3 language, 2 dysarthria, 0 ataxia, 0 neglect). They performed a cranial CT with a finding of a left frontal lobar hematoma, for which Neurosurgery was notified, who indicated urgent surgery. Pending intervention, she remains under observation in the emergency room, with progressive deterioration of the level of consciousness, for which we are notified. Upon arrival, patient at 0 degrees, with signs of aspiration, and GCS 8 (E1, V1, M4), middle pupils with gaze deviation to the left. She was admitted urgently to the ICU and underwent orotracheal intubation and osmotherapy. Examination on admission: BP 140/70 mmHg, HR 80 bpm, SpO2 95% conventional. Examination on admission: Spontaneous eye opening, lazy mydriatic pupils. Mutist. No motor response to verbal or painful stimuli. CA: rhythmic, muted tones. Mitral murmur II / VI. PA: generalized hypophonesis. Abdomen: soft, depressible, without signs of peritoneal irritation. Lower Limbs: No edema. Apache score: 25. Apache Category II: Brain Hemorrhage (SAH, ICH, SDH). Physical exploration: Temperature (C): 37.3; Heart rate: 66 bpm; Respiratory rate: 27 RPM; O2 saturation: 96%; Non-invasive BP: 88/56 (67). Supplementary tests: 21May2021: Cranial CT: Large acute left frontal intraparenchymal hematoma that generates a large mass effect with signs of subfacial and slight descending transtentorial herniation, and with intraventricular hemorrhage. In the postcontrast study: Filiform right vertebral artery with distal repermeabilization. Possible fetal origin of the left PCA. Chest X-Ray (supine position), no parenchymal infiltrates, no signs of fluid overload, no cardiomegaly, TOT, normalized CVC. 22May2021: Control baseline cranial CT 24h after decompressive craniectomy. Summary evolution: She returned from the operating room connected to MV and under the effects of sedation and analgesia. Surgical incidents: Patient in supine position with head lateralized to the right. Incision. Extended frontal parietal temporal craniectomy. A very edematous brain is observed that begins to herniate. An acute frontoparietal subdural hematoma is evacuated. Evacuation of a very extensive intraparenchymal hematoma. Comprehensive and compressive hemostasis is performed with surgicel. Dural not hermetic closure. Bone is sent in biobank. Subgaleal drainage without vacuum. A right frontal PIC is placed. Anesthetic incidents: She arrived in the operating room intubated under the effects of sedation and analgesia. Cefazolin prophylaxis. Maintenance with sevorane. Dexamethasone and levetiracetam are administered. Potassium and HCO3 are replenished. 2 PRBC and 2 platelets are transfused. Accurate start of NA. Refers to anesthesia in a verbal report of tension lability. The family was informed of a bad prognosis. They request extreme anointing. Presents an episode of desaturation and hypotension in relation to progression of TOT with left atelectasis that is resolved by mobilizing the TOT, leaving a mark in the commissure of 21-22. She left with PEEP of 8. Coinciding with the episode, she presented self-limited generalized tremor. Levetiracetam is increased to 1.5 g / 12h ivA follow-up CT scan was requested at 24h showing an increase in the size of the acute left supratentorial intraparenchymal hemorrhage, of the acute subdural hematoma, as well as the volume and hemorrhage of the ventricular system. New onset foci of subarachnoid hemorrhage and intra-axial pneumocephalus. We request consultation to Neurosurgery who reject surgical treatment. Given the situation, the foreseeable consequences and, in agreement with the family, we made the adequacy of the treatment effort. Transplant Coordination is notified for its evaluation. In the afternoon, on call, due to abundant bronchorrhea and low-grade fever, we extracted selective bronchial aspiration for multiarray film, being positive for S. aureus, covering with linezolid and ceftriaxone. Later they warn us that it is meticillin-sensitive. The transplant unit was informed that it will reevaluate the case next day. In the morning of 25May2021, the former pharynx is positive for SARS-CoV-2 PCR. Left lobar frontal intraparenchymal hematoma open to ventricles with midline displacement and transtentorial herniation. Decompressive craniectomy with evacuation of hematoma. 22May2021: Increase in the size of acute left supratentorial intraparenchymal hemorrhage, acute subdural hematoma, as well as volume and ventricular system hemorrhage. New onset foci of subarachnoid hemorrhage and intra-axial pneumocephalus. Adequacy of the Treatment Effort. Exitus lethalis. The action taken in response to the events for acetylsalicylic acid and ticagrelor was dose not changed. The patient died on 25May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage; vaccination failure; SARS-CoV-2 test positive


VAERS ID: 1428157 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Akathisia, Increased bronchial secretion, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (narrow), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PITAVASTATINA CINFA; URSOBILANE; EDOXABAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210641756

Write-up: MOTOR RESTLESSNESS; INNER RESTLESSNESS; RAFT PRODUCTION; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [ ES-AEMPS-902043] concerned a 62-year-old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 17-MAY-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included pitavastatin 25 mg, ursodeoxycholic acid 300 mg, and edoxaban used for unknown indication. On 17-MAY-2021, the patient experienced raft production and fever. On 18-MAY-2021, he experienced inner restlessness. On 20-MAY-2021, the patient experienced motor restlessness. On an unspecified date, the patient died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of inner restlessness, raft production, motor restlessness and fever on an unspecified date. This report was serious (Death).; Sender''s Comments: V0:20210641756-covid-19 vaccine ad26.cov2.s-raft production,fever,inner restlessness,motor restlessness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: INNER RESTLESSNESS; RAFT PRODUCTION; MOTOR RESTLESSNESS; FEVER


VAERS ID: 1428162 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-17
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210647442

Write-up: FULMINANT HEART ATTACK; This spontaneous report received from social media platform (news and other form) reported via a company representative concerned a 72 year old of unspecified sex and unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-JUN-2021, the patient died from fulminant heart attack a few hours after being vaccinated. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210647447 and 20210647445.; Sender''s Comments: V0: 20210647442-COVID-19 VACCINE AD26.COV2.S-Fulminant heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FULMINANT HEART ATTACK


VAERS ID: 1428171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Carotid artery thrombosis, Cerebral artery thrombosis, Cerebral infarction, Computerised tomogram head, Electrocardiogram, Hemiparesis, NIH stroke scale, Ultrasound scan
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder (Strong family risk factor for cerebrovascular disorders); Hypercholesterolemia; Hypertension; Hypothyroidism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: computed tomographic angiography; Result Unstructured Data: Test Result:on the right M1 + Internal carotid artery; Comments: total blockages on the right. A plaque that looks ulcerative in the right bifurcation plane. In perfusion images, the right infarct nucleus covers almost the entire middle cerebral artery vascular area.; Test Date: 202104; Test Name: head ct; Result Unstructured Data: Test Result:on the right M1 + Internal carotid artery; Comments: total blockages on the right. A plaque that looks ulcerative in the right bifurcation plane. In perfusion images, the right infarct nucleus covers almost the entire middle cerebral artery vascular area.; Test Date: 20210420; Test Name: head ct; Result Unstructured Data: Test Result:mass effect associated with cerebral infarction; Comments: presses badly the left side; Test Date: 202104; Test Name: ECG; Result Unstructured Data: Test Result:no arrhythmias; Comments: In the ECG no arrhythmias in the heart rate and in the monitoring.; Test Date: 202104; Test Name: NIHHS; Result Unstructured Data: Test Result:16 p.; Test Date: 201602; Test Name: cervical ultrasound; Result Unstructured Data: Test Result:at that time mild calcareous plaque, no significan; Comments: at that time mild calcareous plaque, no significant stenosis.
CDC Split Type: FIPFIZER INC2021682046

Write-up: This is a spontaneous report from a contactable physician. A 72-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 15Apr2021 (Batch/Lot Number: EW4815) as single dose for covid-19 immunisation. Medical history included Diabetes Mellitus 2, hypertension, hypercholesterolemia, hypothyroidism. Patient had a strong family risk factor for cerebrovascular disorders. Patient didn''t not smoke, does not use alcohol. No antithrombotic medications. The patient''s concomitant medications were not reported. In Feb2016 cervical ultrasound, at that time mild calcareous plaque, no significant stenosis. On 11Apr2021, the condition was fluctuating somehow abnormally. On 13Apr2021, from muscle weakness and fatigue, no clear hemio symptoms. On 15Apr2021, Received the first dose of Pfizer coronary vaccine. For 2 days later, the left limb pair occasionally clumsy. NIHSS 16p. On 18Apr2021, due to left side paralysis symptom (Hemiparesis (left)) patient attended to emergency room, preceded by intermittent weakness of the left limb for several days. On 18Apr2021, found extensive cerebral infarction, occluded right middle cerebral artery and inner carotid artery. Head CT + computed tomographic angiography statement on the right M1 + Internal carotid artery total blockages on the right. A plaque that looks ulcerative in the right bifurcation plane. In perfusion images, the right infarct nucleus covers almost the entire middle cerebral artery vascular area. In the ECG heart rate and no arrhythmias in the monitoring. No dissolution therapy (already limiting ischemia). It was also limited to thrombectomy due to already widespread ischemia. Acetylsalicylic acid only for antithrombotic. Klexane for thromboprophylaxis. Total sensorimotor left. hemi, left. neglect and left hemianopia, turn right, left alafacial weakness. Speech has been conserved. On 19Apr2021, didn''t Resuscitate decision. On 20Apr2021, in the CT of the head associated with cerebral infarction mass effect, presses the left side of the pancreas. Discussed with a neurosurgeon, the prognosis for recovery is modest, not going for neurosurgical procedures. On 21Apr2021 at 02:20, found in the room dead of a stroke. The outcome of events was fatal. The patient died on 21Apr2021. 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: Cerebral infarction/ cerebral infarction mass effect/ stroke; occluded right middle cerebral artery and inner carotid artery; occluded right middle cerebral artery and inner carotid artery; Hemiparesis (left)


VAERS ID: 1428180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-28
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Fatigue, Hypoxia, Pyrexia, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (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: 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: AFib (Cardiac Arrhythmia by Atrial Fibrillation under AVK); Cardiomyopathy; COVID-19; Hypertension arterial; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728899

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Fatigue extreme; Hypoxia; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021057653. A 94-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- EJ6789), intramuscularly, administered in Arm Left on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- EM0477), intramuscularly, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EM0477) as DOSE 1, SINGLE for covid-19 immunization. Medical history included atrial fibrillation from an unknown date, Cardiac Arrhythmia by Atrial Fibrillation. The patient was diagnosed with covid-19 on an unknown date, hypertension from an unknown date, ischaemic stroke on an unknown date, cardiomyopathy from an unknown date. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced fatigue extreme, hypoxia, Appearance of fever/pyrexia. The patient was diagnosed with covid-19 by positive sars-cov-2 test. The patient died on an unknown date in 2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death of the patient, without further information


VAERS ID: 1428232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CR9570 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Auscultation, Blood creatinine, Blood glucose, Blood pressure measurement, Blood sodium, Body temperature, Dehydration, Electrocardiogram, General physical health deterioration, Heart rate, Hyperhidrosis, Hyponatraemia, Musculoskeletal pain, Oxygen saturation, Pyrexia, Respiratory rate
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; INEXIUM [ESOMEPRAZOLE SODIUM]; ASPEGIC [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Below knee amputation; Foot discomfort; Iliac artery restenosis (stenosis of primary iliac arteries); Mycosis; Peripheral arterial disease; Peripheral arterial occlusive disease; Pressure sore; Surgery; Type 2 diabetes mellitus (non-insulin dependent diabetes without drug treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: pulmonary and cardiac auscultation; Result Unstructured Data: Test Result:without apparent abnormalities; Test Date: 20210404; Test Name: Blood creatinine; Result Unstructured Data: Test Result:92 mg/l; Test Date: 20210404; Test Name: Glucose; Test Result: 167 mg/dl; Test Date: 20210404; Test Name: Blood pressure; Result Unstructured Data: Test Result:88/60 mmHg; Test Date: 20210404; Test Name: hyponatremia; Result Unstructured Data: Test Result:124 mmol/L; Test Date: 20210404; Test Name: fever; Result Unstructured Data: Test Result:39.4 Centigrade; Test Date: 20210404; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation; Comments: AF 138 / min, with rapid ventricular response; Test Date: 20210404; Test Name: Heart rate; Result Unstructured Data: Test Result:140 bpm; Test Date: 20210404; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210404; Test Name: Respiratory rate; Result Unstructured Data: Test Result:40 rpm
CDC Split Type: FRPFIZER INC2021688045

Write-up: Hypotonic dehydration; Atrial fibrillation; very painful buttocks.; deep hyponatremia; Fever; progressing intermittently/deterioration of the general condition; sweating; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. Regulatory Authority Report Number : FR-AFSSAPS-BX20215267. Safety Report Unique Identifier : FR-AFSSAPS-2021067896. A 73-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 23Mar2021 (Lot Number: CR9570) as single dose for covid-19 immunisation. Medical history included Peripheral arterial occlusive disease, Below knee amputation, Type 2 diabetes mellitus, Iliac artery restenosis, non-insulin dependent diabetes without drug treatment, arteriopathy of the lower limbs: stenosis of primary iliac arteries, bridged and re-stented, left femoro-popliteal bypass, trophic disorders of the left foot, right transtibial amputation, general condition stable with episodes of mycosis and pressure sores. Concomitant medications included clopidogrel bisulfate (PLAVIX); esomeprazole sodium (INEXIUM); acetylsalicylic acid (ASPEGIC). The patient experienced hypotonic dehydration (death) on 04Apr2021, atrial fibrillation (medically significant) on 04Apr2021, fever (medically significant) on 25Mar2021, progressing intermittently/deterioration of the general condition (medically significant) on 25Mar2021, sweating (medically significant) on 25Mar2021, very painful buttocks (medically significant) on 04Apr2021, deep hyponatremia (medically significant) on 04Apr2021. Fever on day 2 after the 1st dose of the Comirnaty vaccine, persistent, deterioration of the general condition and discovery of deep dehydration and atrial fibrillation on day 12 with death the next day. Appearance of fever on day 2 of vaccination progressing intermittently and sweating treated with paracetamol with partial regression. Consultation on day 12 in front of deterioration of the general condition; on clinical examination fever at 39.4 degrees, respiratory rate 40 rpm, blood pressure 88/60 mmHg, oxygen saturation 98%, heart rate 140 bpm. Presence of very painful buttocks. Antibiotic therapy with amoxiciline / clavulanic acid already started by attending physician. No complaints, patient who responded to simple orders, pulmonary and cardiac auscultation without apparent abnormalities. Laboratory data: deep hyponatremia at 124 mmol / L, glucose 167 mg / dl, blood creatinine 92 mg / L. ECG: atrial fibrillation 138 / min, with rapid ventricular response. Evolution: hydration by NaCL 750 ml, treatment with amoxicillin / clavulanic acid, paracetamol, monitoring for 2 hours with return home and death the next day (05Apr2021) at home. The outcome of the event Hypotonic dehydration was fatal, Sweating was recovering, other events was not recovered. The patient died on 05Apr2021 due to event hypotonic dehydration. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypotonic dehydration


VAERS ID: 1428233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-20
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood urea, Body temperature, C-reactive protein, Drug ineffective, Fibrin D dimer, Haemoglobin, Lymphopenia, Mean cell volume, Oxygen saturation, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (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: 2021-02-23
   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: LASILIX FAIBLE; KARDEGIC; IKOREL; TAHOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis; Exposure to COVID-19; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: creatinine; Result Unstructured Data: Test Result:156 umol/l; Test Date: 202102; Test Name: blood potassium; Result Unstructured Data: Test Result:5.22 mmol/L; Test Date: 202102; Test Name: urea; Result Unstructured Data: Test Result:13.87 mmol/L; Test Date: 202102; Test Name: body temperature; Result Unstructured Data: Test Result:feverish; Test Date: 202102; Test Name: C-reactive protein; Result Unstructured Data: Test Result:93.9 mg/l; Test Date: 202102; Test Name: fibrin D dimer; Result Unstructured Data: Test Result:2070 ng/ml; Test Date: 202102; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.1 g/dl; Test Date: 202102; Test Name: lymphopenia; Result Unstructured Data: Test Result:460 /mm3; Test Date: 202102; Test Name: MCV; Result Unstructured Data: Test Result:82.7; Test Date: 202102; Test Name: oxygen saturation; Test Result: 93 %; Comments: under 1 liter of oxygen; Test Date: 202102; Test Name: sars-cov-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021689043

Write-up: COVID-19 aggravated; COVID-19 aggravated; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB FR-AFSSAPS-CN20211213, Safety Report Unique Identifier FR-AFSSAPS-202103671. An 89-year-old male patient received BNT162b2 (COMIRNATY), dose 1 intramuscularly on 31Jan2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included deep vein thrombosis and pulmonary embolism from an unknown date and unknown if ongoing. The patient received medication assistance in the morning, and could walk without technical assistance. Allergic history were not specified. The patient had no history of COVID-19. The patient lived with a partner at home and was in contact with his partner: PCR covid positive partner on 13Feb2021. The patient was then negative (PCR test). Concomitant medication(s) included furosemide (LASILIX FAIBLE) taken for an unspecified indication from 01Jan2018 to an unspecified stop date; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication from 01Jan2018 to an unspecified stop date; nicorandil (IKOREL) taken for an unspecified indication from 01Jan2018 to an unspecified stop date; atorvastatin calcium (TAHOR) taken for product used for unknown indication from 01Jan2018 to an unspecified stop date. No recent changes in processing. No information on immediate post-vaccination effects. The patient was referred by the fire brigade for dyspnea which had been evolving for 48 hours, feverish, with chills, with chest tightness, no real chest pain. There was no anosmia, no ageusia, no headache, no transit disorders. Note that the patient was in contact with his partner: PCR covid positive partner on 13Feb2021. The patient was then negative. On arrival in the department, the patient was feverish, his hemodynamics were stable. The saturation was 93% under 1 liter of oxygen. The sounds of the heart were regular, with no obvious murmurs. There was no sign of cardiac decompensation, no sign of deep vein thrombosis. The patient was eupneic at rest under 1 liter of oxygen, the vesicular murmur was bilateral and symmetrical without added noise. He had rhinitis. The abdomen was flexible, compressible, painless. The patient was disoriented but coherent, there was no sign of neurological localization. The biology carried out found the following biological anomalies: a biological inflammatory syndrome with a CRP at 93.9 mg / L without associated hyperleukocytosis; lymphopenia at 460 / mm3; an increase in Ddimers to 2070ng / mL; normocytic anemia with hemoglobin at 10.1g / dL, MCV at 82.7fL; an acute on chronic renal failure with a creatinine level of 156umol / L of functional appearance with a urea at 13.87mmol / L, with a usual creatinine level of around 110umol / L, hyperkalaemia at 5.22mmol / L. Reinforced contact and droplet isolation was introduced. Corticosteroid therapy with Dexamethasone 6 mg was started. An anticoagulation by heparin calcium was started, not being able to eliminate an embolic process. The anticoagulation was relayed in the service by tinzaparin INNOHEP. The patient deteriorated suddenly during the night of 21Feb2021 to 22Feb2021, with an increase in oxygen requirements of up to 15 liters and fecaloid vomiting, the patient''s abdomen being painless, flexible, compressible and transit preserved. Death on 23Feb2021 at 8.15 a.m. No autopsy performed. The reported event was "COVID-19 aggravated", onset date 20Feb2021, with fatal outcome. Existence of an acute pathology or a specific complaint in the days preceding death or the days preceding vaccination was unspecified. No existence of a chronic pathology in the process of decompensation or aggravation.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1428277 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / 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: DUROGESIC; LEVOTHYROX; AMOXICILLIN; SPIOLTO RESPIMAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (Lingual neoplasia); Osteoradionecrosis (of the mandible); Radiotherapy; Surgery (supplemented by radiotherapy given an incomplete resection and lymph node invasion); Surgery (complete resection and multiple reconstructive procedures)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021682045

Write-up: Death NOS/patient died; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20213704, Safety Report Unique Identifier FR-AFSSAPS-2021067152. A 59-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular on 26May2021 13:20 (Lot Number: FC3558) as dose 1, single for COVID-19 immunisation. The patient''s medical history included lingual neoplasia operated on in 2008 supplemented by radiotherapy given an incomplete resection and lymph node invasion. During the course of radiotherapy, the patient presented with osteoradionecrosis of the mandible requiring complete resection with multiple reconstructive procedures. Concomitant medications included fentanyl (DUROGESIC); levothyroxine sodium (LEVOTHYROX); amoxicillin; olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT); all taken for an unspecified indication, start and stop date were not reported. On 27May2021, the patient died (death NOS) at 8 p.m. (the day after the vaccination). No information on the circumstances. The patient died on 27May2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1428278 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anoxia, Brain oedema, Cardio-respiratory arrest, Computerised tomogram, Death, Toxicologic 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), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric perforation; Lumbar spinal cord lesion without spinal bone injury
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:no pulmonary embolism, no cerebral thrombosis, no; Comments: no pulmonary embolism, no cerebral thrombosis, no cerebral hemorrhage. Cerebral edema secondary to anoxia.; Test Name: toxicological screening; Test Result: Negative
CDC Split Type: FRPFIZER INC2021728876

Write-up: Cerebral edema secondary to anoxia; Cerebral edema secondary to anoxia; Cardio-respiratory arrest; Death unexplained; This is a spontaneous report downloaded from the Regulatory Authority-WEB, Regulatory authority number (FR-AFSSAPS-LY20216196). A contactable physician reported that a 42-year-old male patient received a dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via intramuscularly, on 21May2021, as single dose for COVID-19 immunisation while he was hospitalized. The patient''s medical history included gastric perforation and lumbar spinal cord lesion without spinal bone injury. It was unknown if the patient had history of COVID19. The patient''s concomitant medications were not reported. On 22May2021, the patient had cardio-respiratory arrest, no flow indeterminate and low flow for 30 minutes. Retained the of rhythm after 1 mg of adrenaline administration. No argument for picture of myocardial infarction. The patient deceased on an unspecified date in May2021. It was discovered that a suspicious lung injury associated with secondary adrenal and cerebral lesions. Autopsy was performed at the request of agency(regardless of the question of the vaccine) where anatomical pathology examination was done during this autopsy. The results of autopsy showed no clear etiology for this cardiac arrest. The patient lab tests and procedures which included computerized tomogram: no pulmonary embolism, no cerebral thrombosis, no cerebral hemorrhage and cerebral edema secondary to anoxia and toxicologic test: negative on an unspecified date. The patient received treatment for cardio-respiratory arrest with 1 mg of adrenaline. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1428287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: ESPFIZER INC2021689348

Write-up: blood clot; This is a spontaneous case received from a contactable consumer or non hcp (patient''s friend) received through Medical Information Team. This is the first of two cases. A 42-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died from a blood clot due to the vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Lot/batch number is missing. Follow-up attempts are needed in order to obtain this information.; Reported Cause(s) of Death: a blood clot due to the vaccine


VAERS ID: 1428289 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain, Electrocardiogram, Investigation
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: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder
Allergies:
Diagnostic Lab Data: Test Name: ECGs; Result Unstructured Data: Test Result:normal previous ECGs; Comments: normal previous ECGs; Test Date: 202102; Test Name: Medical visit; Result Unstructured Data: Test Result:Nothing to report; Comments: Nothing to report
CDC Split Type: FRPFIZER INC2021687980

Write-up: death due to cardio respiratory arrest; pain in the chest; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20212207, Safety Report Unique Identifier FR-AFSSAPS-2021068966. A 38-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via intramuscular on 01Jun2021 (at 38 years old, Lot Number: FC2229) as a single dose for covid-19 immunization. Medical history included anxiety disorder. The patient''s concomitant medications were not reported. The patient previously took alprazolam for anxiety disorder. Medical visit in February 2021: Nothing to report, normal previous ECGs. Sick leave the previous week for anxiety, supported by ALPRAZOLAM for 15 days. On 01Jun2021, he received a first injection of COMIRNATY no problem immediately following the vaccination and after the 15-minute monitoring. On 03Jun2021, pain in the chest after 40 minutes of running and death due to cardio-respiratory arrest. For the declaring physician, there is another medical explanation than the vaccination for the manifestations observed: autopsy requested. The outcome of the events was fatal. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardio respiratory arrest; pain in the chest


VAERS ID: 1428292 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASILIX [FUROSEMIDE]; SPIRONOLACTONE; AMLOR; TRIATEC [CAFFEINE CITRATE;CODEINE PHOSPHATE;PARACETAMOL]; EUPRESSYL [URAPIDIL]; PRAVASTATIN; MIMPARA; CALTRATE 600; RENVELA; UVEDOSE; NOVONORM; LANTUS; NOVORAPID; DUPHALAC [LACTULOSE]; DOLIPRANE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal nodule (Concept of a stable 12mm left adrenal nodule); Anomaly arterial (Atheromatous and calcium infiltration of the arteries of the lower limbs); Arterial hypertension; Bilateral pleural effusion (Minimal bilateral pleural effusion, possibly related to overload (Apr2021).); Diabetes (Insulin-requiring diabetes); Dyslipidemia; End stage renal failure (Stage V chronic renal failure in diabetic nephropathy on peritoneal dialysis (peritoneal dialysis)); Hypoglycemic coma; Lung nodule (Check Mar2021:size Increase compared to 2016 of right lower lobe nodule,infracentimetric(8 mm)); Nephropathy (Diabetic nephropathy); Obesity (weight 107 kg, height 170 cm); Obstructive sleep apnea syndrome (equipped); Retinopathy (Diabetic retinopathy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021688136

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from a regulatory authority, regulatory authority number FR-AFSSAPS-PS20211229, Safety Report Unique Identifier FR-AFSSAPS-2021067937. A 73-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 28May2021 12:43 (Lot Number: FA7082) (at age of 73-year-old) as 1st dose, single for covid-19 immunisation. Medical history included obesity, End stage renal failure, diabetes, retinopathy, nephropathy, hypoglycaemic coma from 2018, Arterial hypertension, Dyslipidemia, sleep apnoea syndrome, adrenal nodule, Lung nodule, bilateral pleural effusion, and Anomaly arterial.Concomitant medication(s) included furosemide (LASILIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLOR) taken for an unspecified indication, start and stop date were not reported; caffeine citrate, codeine phosphate, paracetamol (TRIATEC [CAFFEINE CITRATE;CODEINE PHOSPHATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported; urapidil (EUPRESSYL [URAPIDIL]) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; cinacalcet hydrochloride (MIMPARA) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CALTRATE 600) taken for an unspecified indication, start and stop date were not reported; sevelamer carbonate (RENVELA) taken for an unspecified indication, start and stop date were not reported; colecalciferol (UVEDOSE) taken for an unspecified indication from Feb2021 to an unspecified stop date; repaglinide (NOVONORM) taken for an unspecified indication, start and stop date were not reported; insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported; insulin aspart (NOVORAPID) taken for an unspecified indication, start and stop date were not reported; lactulose (DUPHALAC [LACTULOSE]) taken for an unspecified indication, start and stop date were not reported; paracetamol (DOLIPRANE) taken for an unspecified indication, start and stop date were not reported; nefopam hydrochloride (ACUPAN) taken for an unspecified indication, start and stop date were not reported; lidocaine (VERSATIS) taken for an unspecified indication, start and stop date were not reported; darbepoetin alfa (ARANESP) taken for an unspecified indication from 22Apr2021 to an unspecified stop date. The patient experienced death unexplained on 28May2021 (the day of administration ). It was not reported if an autopsy was performed. Description of the effect: The patient presenting numerous comorbidities, including chronic end-stage kidney disease and diabetes. Medical background : Insulin-requiring diabetes , Stage V chronic renal failure in diabetic nephropathy on peritoneal dialysis (peritoneal dialysis , refusal of transplantation by the patient), Diabetic retinopathy and nephropathy, Hypoglycemic coma in 2018, Arterial hypertension, Dyslipidemia,Atheromatous and calcium infiltration of the arteries of the lower limbs, Obesity (weight 107 kg, height 170 cm) , Severe obstructive sleep apnea syndrome, Probable metabolic syndrome / hepatic steatosis, Concept of a stable 12mm left adrenal nodule, Lung nodule. Check Mar2021: Increase in size compared to 2016 of the right lower lobe nodule, remaining infracentimetric (8 mm). Minimal bilateral pleural effusion, possibly related to overload (Apr2021). Way of life: Divorced patient, lives alone, 2 sons. No alcohol-smoking poisoning. Passage of a professional nurse 4 times a day for peritoneal dialysis and insulin injections. Autonomous in the activities of daily living. History of COVID: no, test not done. 28May2021 at 12.43, injection of the vaccine, post-vaccination monitoring for 45 minutes without special features, around 1.30 pm - departure of the patient from the vaccination center. At 4 pm the Urgent medical aid service was called by a professional nurse intervening at the home of the patient, found dead in her chair. The family was present at home (moreover, patient lives alone),Death within 1 hour after vaccination. To that date a cause of death has not been identified. The prosecution will decide on the autopsy or not. Conclusion of our analysis. 1) Chronologically, the data are consistent with the role of the vaccine in causing this unexplained death between 1 and 2.5 hours after administration in a patient with a long medical history. 2) On the semiological level, in the absence of the result of a possible autopsy and of a clear medical conclusion concerning the cause of this event, a coincident non-drug cause cannot be ruled out. The role of the underlying chronic pathologies must be taken into account in the occurrence of this death. There is no argument for an anaphylactic reaction. 3) From a bibliographical point of view, among the known and expected effects (summary of product characteristics) of this vaccine which may possibly lead to death, only anaphylaxis can be discussed. It should be noted that cardiac / cardiovascular effects, in particular such as arrhythmia or hypertensive surges, are reported in national and worldwide monitoring. In the worldwide database, 101 cases of death (unspecified as to its cause) after the administration of a Comirnaty vaccine are recorded, without this constituting a signal. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1428295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-04-07
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: COVID Test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728708

Write-up: congested lung but saturation ok; Vaccination failure; COVID with PCR with identification of the variant; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-TO20213797. A 92-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6789) via intramuscular on 09Feb2021 as 2nd dose, single and first dose (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ES6788) via intramuscular on 19Jan2021 as 1st dose, single both for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 07Apr2021 COVID with PCR with identification of the variant. On 12Apr2021 congested lung but saturation ok. On 19Apr2021 still very crowded despite aerosol no cyanosis. On 21Apr2021 transferred to hospitalization unit in the face of worsening clinical condition. On 15May2021 death of the patient in hospital. Evolution: patient died of the consequences on 15May2021 as a result of his infection with COVID 19. An autopsy was not performed. Outcome of events were fatal. Follow-up (21Jun2021): This is a follow-up report from Product Complaint Team. New information provided from division includes: The complaint for LOE/adverse event 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 EJ6789. 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. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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 possible. No further information expected.; Reported Cause(s) of Death: INFECTION COVID 19


VAERS ID: 1428340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-04-01
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Blood test, Dyspnoea, Fatigue, Pancytopenia, Platelet count, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: Diabetic; Neoplasm malignant (Patient has history of, or current, malignancy); Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Bone marrow biopsy; Result Unstructured Data: Test Result:unknown; Test Date: 202012; Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210401; Test Name: Blood test; Result Unstructured Data: Test Result:pancytopenia; Test Name: Platelet count; Result Unstructured Data: Test Result:148; Comments: last platelet count before vaccine; Test Name: Platelet count; Result Unstructured Data: Test Result:9; Comments: lowest platelet count after vaccine; Test Date: 20210401; Test Name: Platelet count; Result Unstructured Data: Test Result:unknown; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021690482

Write-up: tiredness; breathlessness; Pancytopenia; This is a spontaneous report received from a contactable Healthcare Professional by Pfizer from the a regulatory authority(RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106090734582260-MXYUG. Safety Report Unique Identifier GB-MHRA-ADR 25442374. A 75-year-old male patient received his first dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration as a single dose on 31Jan2021 (lot number unknown) for COVID-19 immunisation. The patient''s medical history included diabetes mellitus, neoplasm malignant, non-tobacco user. The patient was completely fit and healthy, was playing tennis. He was only borderline diabetic and on very low dose metformin. There was no additional medical history, not already provided, that relates to previous venous or arterial thromboses. The patient did not have any previous reactions to medications, especially heparin or anticoagulants. The patient had no confirmed or suspected autoimmune or inflammatory disease, including vasculitis. Patient had no history of, or concurrent, intracranial malignancy and had no concurrent or recent intracranial infections. The patient did not have a recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient had no recent trauma/head injury. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Past drugs included heparin and metformin. The patient experienced pancytopenia on 01Apr2021, extremely tired and breathless on an unspecified date with fatal outcome. The events were reported as serious due to hospitalization, resulted in death, life-threatening, disability and medically significant. The patient had entirely normal blood results in Dec2020. After first Pfizer jab he started to feel breathless and extremely tired. Blood tests were performed after vaccine due to breathlessness and extreme tiredness and showed pancytopenia. Bone marrow biopsy result was unknown. Platelet count was measured on 01Apr2021 and then weekly afterwards. The lowest platelet count after vaccine (usual normal range 150-450) was 9 and the last platelet count before vaccine was 148. The patient was reviewed by a haematologist and was diagnosed with pancytopenia. Haemorrhage was not identified. No autopsy was performed. The reporter considered that this report related to possible blood clots or low platelet counts. COVID-19 virus test performed on an unspecified date was negative. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pancytopenia; breathlessness; extremely tired


VAERS ID: 1428344 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3/21 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021683486

Write-up: Death; This is a spontaneous report received from a contactable consumer by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106090800214900-WYYK2. Safety report unique identifier GB-MHRA-ADR 25442388. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: 3/21) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death on 19Jan2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1428490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Decreased appetite, Gastrointestinal inflammation, Hepatic failure, Lethargy, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: Kidney failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021690476

Write-up: kidney failure; kidney failure; lethargic; Inflammation of the abdomen; Loss of appetite; Organ failure/ Liver failure; This is a spontaneous report received from a contactable consumer (patient''s brother) from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106091910436780-L7ASM, Safety Report Unique Identifier GB-MHRA-ADR 25447245. A 72-year-old male patient received his second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration as a single dose on 28Apr2021 (lot number unknown) for Covid-19 immunization. The patient''s medical history included renal failure. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historic vaccine included first dose of bnt162b2 (COMIRNATY) for Covid-19 immunization on an unspecified date. The patient experienced Organ failure/ hepatic failure on 07May2021, renal failure/ condition aggravated, lethargic, Inflammation of the abdomen and loss of appetite on an unspecified date, which resulted in death. The patient deteriorated very quickly after receiving his 2nd jab. He became very lethargic, inflammation of the abdomen, loss of appetite and eventually liver and kidney failure that resulted in his death on 07Jun2021- 5 weeks after his 2nd jab. Patient has not tested positive for COVID-19 since having the vaccine. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Liver failure; Kidney failure; lethargic; Inflammation of the abdomen; loss of appetite


VAERS ID: 1428657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021698345

Write-up: passed away from coronavirus; passed away from coronavirus; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient passed away from coronavirus, had received the Pfizer vaccine. 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: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely 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: passed away from coronavirus; passed away from coronavirus


VAERS ID: 1428693 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021752070

Write-up: Severe Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (GR-GREOF-20214238). A 65-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included an unspecified anticoagulant medication. The patient experienced severe pneumonia on 01May2021, which was reported as medically significant and fatal. The patient died on an unspecified date. The cause of death was reported as severe pneumonia. 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: CONCOMITANT DRUGS:ANTICOAGULANT MEDICATION; Reported Cause(s) of Death: Severe Pneumonia


VAERS ID: 1428694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-21
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021753073

Write-up: This is a spontaneous report from a contactable physician. A 72-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included an unspecified oral tranquilizer. The patient experienced severe pneumonia on 21Apr2021, which was reported as medically significant and fatal. The patient died on an unspecified date. The cause of death was reported as severe pneumonia. 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: CONCOMITANT DRUGS:TRANQUILIZER (UNKNOWN) PER OS. (orally); Reported Cause(s) of Death: SEVERE PNEUMONIA


VAERS ID: 1428701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Diabetes mellitus; Hypoacusis
Preexisting Conditions: Medical History/Concurrent Conditions: Epileptic seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021681660

Write-up: GM seizures; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is HU-OGYI-384721. A 76-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 01May2021 (Batch/Lot Number: EX6537) as dose 2, 0.3mL, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypoacusis and dementia. He was nursed at his home for several years. He was also treated on neurology in 2020. September due to suspected epileptic seizure. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 (Batch/Lot Number: ET7205) for COVID-19 immunisation. On 17May2021, the patient had grand mal convulsion (GM seizures). He was submitted to hospital on 17May2021 and died on 23May2021. It was unknown if autopsy was performed. Sender Comment: Grand mal convulsion is not an expected adverse event of COMIRNATY. TTO was 16 days. The patient had suspected epileptic seizure in Sep2020, as well. Based on the above, causality between grand mal convulsion and COMIRNATY is unlikely. No further information is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: GM seizures


VAERS ID: 1428702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall, Femur fracture, General physical health deterioration, Investigation
SMQs:, Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 12
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: Atherosclerosis; Heart failure NYHA class IV; Pertrochanteric fracture of femur, closed; Pneumonia bacterial
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Examinations; Result Unstructured Data: Test Result:pertrochanteric fracture
CDC Split Type: HUPFIZER INC2021689192

Write-up: Death/poor general condition; fall; fall; This is a spontaneous report from a contactable physician downloaded from a regulatory authority HU-OGYI-394021 This spontaneous, serious, medically confirmed case was reported on 27May2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 04May2021 the 87-years-old female patient received the second dose of 0.3 ml BNT162B2 (COMIRNATY) concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) to prevent Covid-19. Medical history included NYHA class IV heart failure, bacterial pneumonia and atherosclerosis, pertrochanteric fracture of femur, closed. Concomitant drugs were not reported. The patient was hospitalized on 09May2021 after a fall. Examinations showed a pertrochanteric fracture which required surgery, but as the patient general condition was bad, she was unfit to have the surgery. Despite treatment, the patient passed away on 13May2021 at 06:10. Autopsy was performed. Further information is not expected. Sender Comment: As the patient was hospitalized because of a fall and then passed away due to her poor general condition, 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 are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: poor general condition


VAERS ID: 1428703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall, Femur fracture, General physical health deterioration, Laboratory test, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 15
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: Atherosclerosis; COPD; Ischemic heart disease; Pneumonia hypostatic
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Examinations; Result Unstructured Data: Test Result:a pertrochanteric fracture on the left side
CDC Split Type: HUPFIZER INC2021689193

Write-up: condition deteriorated; fall; pertrochanteric fracture on the left side; Death/ heart attack contributed to her death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-394121. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscularly on 05May2021 as 0.3 ml single dose for covid-19 immunisation. Medical history included ischemic heart disease, atherosclerosis, chronic obstructive pulmonary disease (COPD) and hypostatic pneumonia. Concomitant drugs were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: Unknown) on unknown date as single dose for covid-19 immunisation. The patient was hospitalized on 14May2021 after a fall. Examinations showed a pertrochanteric fracture on the left side. The patient received surgery, but despite therapy, her condition deteriorated. The patient passed away on 16May2021 at 16:10. The outcome of events fall and pertrochanteric fracture was unknown. The patient died on 16May2021. An autopsy was performed but results were not provided. Sender Comment: As the patient was hospitalized because of a fall and then passed away due to her general condition in association with her primary diseases, the causal relationship is unlikely between the suspected drug and the adverse event. The patient also had a recent heart attack which also contributed to her death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the myocardial infarction and the other events. The reported events likely represent intercurrent medical conditions. 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: heart attack contributed to her death; condition deteriorated


VAERS ID: 1428704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia (cytostatic treatments); COVID-19; COVID-19 pneumonia; GERD; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021730992

Write-up: COVID-19; Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory authority number HU-OGYI-415121. A 79-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: ET6956), via intramuscular route in the left arm on 26Apr2021 as DOSE 2, 0.3 ML, single dose for covid-19 immunization and first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EZ3620), via on an unspecified route of administration on 22Mar2021 as DOSE 1, single for covid-19 immunization. The patient''s medical history included hypertension, covid-19 pneumonia, chronic lymphocytic leukaemia in Feb2003 and received cytostatic treatments, covid-19 and gastrooesophageal reflux disease. The patient''s concomitant medications were not reported. The patient was hospitalized on 04May2021 after experiencing Covid-19 symptoms. Antigen test was positive. The patient received covid therapy, but her respiratory insufficiency progressed and was transferred to the Intensive Care Unit on 09May2021. Despite therapy, permanent improvement of the patients condition could not be reached. The patient passed away on 16May2021 at 18:49 due to Covid-19 pneumonia and ARDS. Sender Comment: The patient got infected with Covid-19 approximately 1 week after the second dose, therefore vaccination failure is considered possible. The case is 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: ARDS; COVID-19


VAERS ID: 1428705 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001939 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hemiparesis, Hypertension, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Joint pain
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Blood pressure; Result Unstructured Data: Increased; Test Date: 20210508; Test Name: Pulse rate; Result Unstructured Data: Rapid pulse
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: (209/120 Hgmm); (115/min); This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (hemiparesis), HYPERTENSION (209/120 Hgmm), HEART RATE INCREASED (115/min) and VACCINATION FAILURE in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001939) for COVID-19 vaccination. The patient''s past medical history included Hypertension and Joint pain. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-May-2021, the patient experienced HEMIPARESIS (hemiparesis) (seriousness criteria death, hospitalization and medically significant), HYPERTENSION (209/120 Hgmm) (seriousness criteria death and hospitalization) and HEART RATE INCREASED (115/min) (seriousness criteria death and hospitalization). On 21-May-2021, the patient experienced VACCINATION FAILURE (seriousness criteria death and hospitalization). The patient died on 21-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood pressure measurement: 209/120 mmhg (High) Increased. On 08-May-2021, Heart rate: 115 (High) Rapid pulse. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment details provided. This fatal case concerns a 66-year-old male with serious unexpected events of hemiparesis, hypertension, heart rate increased, and vaccination failure. Event latency 8 days after first dose mRNA-1273. Outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 66-year-old male with serious unexpected events of hemiparesis, hypertension, heart rate increased, and vaccination failure. Event latency 8 days after first dose mRNA-1273. Outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1428709 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Dyspnoea, Loss of consciousness, SARS-CoV-2 RNA
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (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: Abdominal aortic aneurysm; Hypertension; Ischaemic heart disease; Peripheral vascular disease; Triple vessel bypass graft (triple bypass 18 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: SARS-CoV-2 RNA; Test Result: Negative
CDC Split Type: IEPFIZER INC2021688266

Write-up: BREATHLESSNESS; RUPTURED ATHEROSCLERSIS ABDOMINAL AORTIC ANEURYSM; COLLAPSE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-073777. A 75-years-old male patient received BNT162B2 (COMIRNATY), second dose via intramuscular, administered in right upper deltoid on 11May2021 15:25 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation (at the age of 75 years old). The patient''s medical history/concurrent conditions included hypertension, peripheral vascular disease, abdominal aortic aneurysm (aortic aneurysm), triple vessel bypass graft in 2003, triple bypass 18 years ago (coronary artery bypass), and ischaemic heart disease (myocardial ischaemia). The patient''s concomitant medications were not reported. Historical vaccine included first dose on unspecified dose for covid-19 immunisation. The patient experienced collapse on 11May2021, breathlessness 11May2021 18:25, ruptured atherosclersis abdominal aortic aneurysm on 11May2021. Initial report was received by the HPRA on 12May2021 from a Coroner. This report concerned a 75 years old male who experienced dyspnoea, loss of consciousness and died following vaccination with Comirnaty for COVID-19 immunisation. No information was provided regarding the patient''s concomitant medication. 3 hours post vaccination, the patient experienced breathlessness followed by collapse. Follow-up information was received by the HPRA from a Coroner on 14May2021: On 11May2021, the patient complained of shortness of breath at 18:25. It was noted the patient died within a 3 hour following administration of second dose of Comirnaty. On 13May2021, the post-mortem report indicated that the cause of death was ruptured atherosclerosis abdominal aortic aneurysm. It was noted that nasopharyngeal swab was obtained, which SARS-CoV-2 RNA was not detected. The patient underwent lab tests and procedures which included SARS-CoV-2 RNA: negative on 13May2021. The outcome for events was fatal. At the time of reporting, a Coroner''s autopsy had been directed. An autopsy was performed that revealed ruptured atherosclerosis abdominal aortic aneurysm (aortic aneurysm rupture). No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ruptured atherosclerosis abdominal aortic aneurysm; Autopsy-determined Cause(s) of Death: Ruptured atherosclerosis abdominal aortic aneurysm


VAERS ID: 1428710 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Malaise, SARS-CoV-2 RNA undetectable, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Chronic ischaemic heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: SARS-CoV-2 RNA undetectable; Result Unstructured Data: Test Result:nasopharyngeal swab, not detected.
CDC Split Type: IEPFIZER INC2021688261

Write-up: RUPTURED ACUTE MYOCARDIAL INFARCTION OF THE ANTERIOR ASPECT OF THE LEFT VENTRICLE; unresponsive; FEELING UNWELL; This is a spontaneous report from a contactable other healthcare professional (Coroner) downloaded from the a regulatory authority. The regulatory authority report number is [IE-HPRA-2021-074281]. A 57-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13May2021 (Lot Number: Unknown) as single dose for covid-19 immunization at the age of 57 years old. Medical history included Chronic ischaemic heart disease, unspecified and aortic valve replacement. Concomitant medication(s) included warfarin. The patient experienced feeling unwell on 13May2021, ruptured acute myocardial infarction of the anterior aspect of the left ventricle on 16May2021. Reported as: On 13May2021, following vaccination, the patient felt unwell that night, next day and again on 16May2021. On 16May2021, the patient was found unresponsive on the floor at home. Given the temporal relationship between the first vaccine and death, a Coroner''s autopsy was directed. On 19May2021, the post-mortem report indicated that the cause of death was a ruptured acute myocardial infarction of the anterior aspect of the left ventricle in the context of chronic ischaemic heart disease and aortic valve replacement. It was noted that nasopharyngeal swab was obtained, which SARS-CoV-2 RNA was not detected on 19May2021. The patient died on 16May2021. An autopsy was performed that revealed ruptured acute myocardial infarction of the anterior aspect of the left ventricle. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unresponsive; RUPTURED ACUTE MYOCARDIAL INFARCTION OF THE ANTERIOR ASPECT OF THE LEFT VENTRICLE; FEELING UNWELL; Autopsy-determined Cause(s) of Death: RUPTURED ACUTE MYOCARDIAL INFARCTION OF THE ANTERIOR ASPECT OF THE LEFT VENTRICLE


VAERS ID: 1428758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebral ischaemia, Coma, Paresis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021687995

Write-up: paresis; Coma; cerebral ischaemia; atrial fibrillations; This is a spontaneous report received from a contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-740023. A 80 years old female patient received second dose BNT162B2 (COMIRNATY, lot number ET7205), intramuscular at Arm Right on 01APR2021 at single dose for SARS-CoV-2 vaccination. The medical history included Diabetes and Arthritis rheumatoid. The concomitant medications were not reported. At 9 days after second dose on 10APR2021, the patient experienced cerebral ischaemia, paresis, atrial fibrillations, coma and death after 7 days on 17APR2021. The patient died on 17APR2021. It''s unknown if an autopsy was performed. The cause of death was cerebral ischaemia, paresis, atrial fibrillations, coma. The outcome of the event was fatal. Reporter''s comments:Rheumatoid arthritis, diabetes No follow-up attempts possible. No further information expected.; Reporter''s Comments: Rheumatoid arthritis, diabetes; Reported Cause(s) of Death: paresis; Coma; cerebral ischaemia; atrial fibrillations


VAERS ID: 1428818 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade
CDC Split Type: JPPFIZER INC2021679058

Write-up: Acute cardiac insufficiency; body temperature was 37.5 degrees centigrade / body temperature was 39 degrees centigrade / body temperature was 38 degrees centigrade; This is a spontaneous report from a contactable physician received from a regulatory authority (RA). Regulatory authority report number is v21112718 and v21112921. The patient was a 28-year-old male. Body temperature before vaccination was 36.7 degrees centigrade. Family history was not reported. On 14May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021). On 04Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 28-year-old. On 08Jun2021 (4 days after the vaccination), the patient experienced death. On 08Jun2021 (4 days after the vaccination), the outcome of the event was fatal. Event/cause of death was acute cardiac insufficiency. The course of the event was as follows: On 04Jun2021, on the day of the second vaccination, the patient''s body temperature was 37.5 degrees centigrade. On 05Jun2021, body temperature was 39 degrees centigrade. On 06Jun2021, body temperature was 38 degrees centigrade, for which the patient took a day off work. On 07Jun2021, body temperature was 36.1 degrees centigrade and the patient worked from 12:00 to 21:00. On 08Jun2021, the patient was scheduled to work but did not come to the workplace. A staff visited the patient''s home but could not get in; thus, the staff called a fire department and the patient was found to be dead in the room. Pathological autopsy was conducted at university. As a result of pathological autopsy, cause of death was identified as acute cardiac insufficiency. Outcome of the event body temperature increased was recovered on 07Jun2021. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: At the time of this report, causality was unknown.; Reported Cause(s) of Death: Acute cardiac insufficiency; Autopsy-determined Cause(s) of Death: Acute cardiac insufficiency


VAERS ID: 1428827 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cerebral arterial aneurysm; Consciousness disturbance transient; Late effects of cerebral infarction; Old cerebral infarction; Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade
CDC Split Type: JPPFIZER INC2021679397

Write-up: Cardio-respiratory arrest / Cardiac arrest; Respiratory arrest; This is a spontaneous report from a contactable physician (via a Pfizer sales representative) received from the Agency Regulatory Authority. Regulatory authority report number is v21113766. The patient was a non-pregnant 93-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified prescribed drugs 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. Since the vaccination, the patient has not been tested for COVID-19. Other medical history included histories of atrial fibrillation, old cerebral infarction, cerebral arterial aneurysm, subarachnoid haemorrhage, and persistent disturbance of consciousness. On 04Jun2021 at 10:30 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization (at the age of 93 years old). On 07Jun2021 at 11:45 (3 days after the vaccination) (as reported, pending clarification), the patient suddenly experienced respiratory arrest for about 5 minutes. Throat congestion with some sputum was removed. On 09Jun2021 (5 days after the vaccination), the patient experienced cardio-respiratory arrest / cardiac arrest which resulted in death without treatment. The patient died on 09Jun2021. An autopsy was not performed. Death cause was reported as cardiac arrest. The outcome of respiratory arrest was unknown. Clinical course was reported as follows: The patient received long-term treatment with stable condition. The reporter commented as follows: Her death was considered to be closely related to senility or her underlying diseases, but causality was unknown. The patient was a 93-year and 6-month-old female. Body temperature before vaccination was 37.1 degrees Centigrade. The patient had no specific family history. Additional medical history included late effects of cerebral infarction. Time of vaccination was amended from at 10:30 to 11:40 on 04Jun2021. The causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were reported as below: Advanced age and atrial fibrillation as underlying disease, but she had no tachycardia. Possibilities of senility, newly developed brainstem infarction, or myocardial infarction could not be ruled out. On 07Jun2021 at 11:40 (3 days after the vaccination) (as reported, pending clarification), the patient suddenly experienced cardiac arrest while bathing. Tachycardia was also noted. On 09Jun2021 (5 days after the vaccination), the patient suddenly experienced cardiac arrest and then died. Due to her advanced age, the patient was decided to not receive not receive resuscitation at the time of sudden change. The reporter commented as follows: Possibility of direct involvement of vaccination to her death was considered as low because of her advance age, various underlying diseases, and no symptoms within 2 days of vaccination. Autopsy was not conducted upon request. However, during her hospitalization, the patient had been stable condition; therefore, this case was reported.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1428845 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Brain stem haemorrhage, Computerised tomogram head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210609; Test Name: head CT; Result Unstructured Data: Test Result:Cerebral haemorrhage (Brain stem haemorrhage); Comments: Brain stem haemorrhage
CDC Split Type: JPPFIZER INC2021680695

Write-up: Brain stem haemorrhage; Consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21112791. The patient was an 86-year and 11-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade (Jun2021). 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 07Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jun2021 at around 7:00(1 days 17 hours after the vaccination), the patient experienced Consciousness disturbed. The course of the event was as follows: On 08Jun2021 at 21:00, there was no particular change during bedtime. On 09Jun2021 at 7:00, the patient experienced consciousness disturbed when making rounds. The ambulance was transferred to the reporting physician''s hospital. The patient had a test of Head CT and Brain stem haemorrhage was diagnosed. The seriousness and the causality between the event and BNT162B2 were not provided. Event, brain stem haemorrhage was reported. Onset date of the event was 09Jun2021, around 7:00. The reporter classified the event, brain stem haemorrhage as serious (death).; Reported Cause(s) of Death: Brain stem haemorrhage; Consciousness disturbed


VAERS ID: 1428849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood creatinine, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Cardio-respiratory arrest, Eosinophil count, Gamma-glutamyltransferase, Haemoglobin, Lymphocyte count, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Pyrexia, Red blood cell count, White blood cell count, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; BUFFERIN [ACETYLSALICYLIC ACID]; ENALAPRIL MALEATE; FERROUS CITRATE SODIUM; AMLODIPINE; DOPACOL; PANTOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Dementia; Malnutrition; Myocardial infarction old; Pressure sore
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: GPT; Result Unstructured Data: Test Result:11; Comments: 15:44; Test Date: 20210604; Test Name: GOT; Result Unstructured Data: Test Result:20; Comments: 15:44; Test Date: 20210604; Test Name: basophils; Test Result: 0.7 %; Comments: 15:44; Test Date: 20210604; Test Name: creatinine; Result Unstructured Data: Test Result:1.00; Comments: 15:44; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/69; Comments: 08:00; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:117/87; Comments: 15:44; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:70/46; Comments: 16:00; Test Date: 20210604; Test Name: BUN; Result Unstructured Data: Test Result:27.5; Comments: 15:44; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: 08:00; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: 15:44 (also reported as 15:40); Test Date: 20210604; Test Name: CRP; Result Unstructured Data: Test Result:5.06; Comments: 15:44; Test Date: 20210604; Test Name: eosinophils; Test Result: 1.2 %; Comments: 15:44; Test Date: 20210604; Test Name: gamma-GTP; Result Unstructured Data: Test Result:15; Comments: 15:44; Test Date: 20210604; Test Name: Hb; Result Unstructured Data: Test Result:8.6; Comments: 15:44; Test Date: 20210604; Test Name: lymphocytes; Test Result: 38.2 %; Comments: 15:44; Test Date: 20210604; Test Name: monocytes; Test Result: 5.8 %; Comments: 15:44; Test Date: 20210604; Test Name: neutrophils; Test Result: 54.6 %; Comments: 15:44; Test Date: 20210604; Test Name: SpO2; Test Result: 76 %; Comments: 15:44; Test Date: 20210604; Test Name: plt; Result Unstructured Data: Test Result:280000; Comments: 15:44; Test Date: 20210604; Test Name: RBC; Result Unstructured Data: Test Result:2700000; Comments: 15:44; Test Date: 20210604; Test Name: WBC; Result Unstructured Data: Test Result:26780; Comments: 15:44
CDC Split Type: JPPFIZER INC2021680756

Write-up: cardio-respiratory arrest; WBC markedly increased; Pyrexia/38.5 degrees Centigrade; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21112831. The patient was a 92-year and 7-month-old male. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included dementia, myocardial infarction old, cardiac failure chronic, pressure sore, and malnutrition. Concomitant medications included furosemide (FUROSEMIDE), acetylsalicylic acid (BUFFERIN), enalapril maleate (ENALAPRIL MALEATE), ferrous citrate sodium (FERROUS CITRATE SODIUM), amlodipine besilate (AMLODIPINE), carbidopa hydrate (DOPACOL) and pantethine (PANTOSIN). Family history was not provided. On 03Jun2021 at 10:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jun2021 at 15:44 (also reported as 15:40) (1 day after the vaccination), the patient experienced pyrexia. On 04Jun2021 at 16:15 (1 day after the vaccination), the patient died of cardio-respiratory arrest. It was not reported if an autopsy was performed. The course of the events was as follows: On 04Jun2021 at 08:00, KT (body temperature) was 36.6 degrees Centigrade and BP (blood pressure) was 116/69. On 04Jun2021 at 15:40, the patient developed breathing difficulty accompanied by phlegm. He made reaction when spoken to. On 04Jun2021 at 15:44 (also reported as 15:40), KT was 38.5 degrees Centigrade, BP was 117/87 and SpO2 (oxygen saturation percutaneous) was 76%. Blood samples were obtained, and the results was as follows: White blood cells (WBC) 26,780; Red blood cells (RBC) 2,700,000; Hb (haemoglobin) 8.6; plt (platelets) 280,000; neutrophils 54.6%; lymphocytes 38.2%; monocytes 5.8%; basophils 0.7%; eosinophils 1.2%; C-reactive protein (CRP) 5.06; glutamic-oxaloacetic transaminase (GOT) 20; glutamic pyruvic transaminase (GPT) 11; gamma-GTP (gamma glutamyl transpeptidase) 15, blood urea nitrogen (BUN) 27.5 and creatinine 1.00. On 04Jun2021 at 16:00, BP was 70/46. Complexion ill was noted. On 04Jun2021 at 16:15, he developed cardio-respiratory arrest. The patient died due to pyrexia and cardio-respiratory arrest on 04Jun2021 while unknown for the remaining event. It was unknown if autopsy was performed The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event (pyrexia and cardio-respiratory arrest) and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had various underlying diseases, but around the vaccination day, no change was noted in his physical condition (soon before the vaccination, he ate all of his lunch). Considering that pyrexia acutely occurred, and 30 minutes after cardio-respiratory arrest developed and the above mentioned blood test data, WBC markedly increased, a possibility that BNT162b2 influenced the event could not be ruled out.; Reported Cause(s) of Death: cardio-respiratory arrest; pyrexia


VAERS ID: 1428860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Coronavirus test
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), COVID-19 (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: Angina pectoris; Myocardial infarction; Stent placement
Allergies:
Diagnostic Lab Data: Test Name: Coronavirus test; Result Unstructured Data: Test Result:negative
CDC Split Type: JPPFIZER INC2021682327

Write-up: Acute cardiac death; This is a spontaneous report from a contactable pharmacist and from a regulatory authority from the same contactable pharmacist. Regulatory authority report number is v21113107. The male patient was 76-years and 7-months old. In 2009, 12 years before from the reporting date, a stent was placed due to myocardial infarction and the patient was followed up thereafter for angina pectoris. Body temperature before vaccination was unknown. 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 10Jun2021 at around 06:00 (one day after the vaccination), the patient experienced acute cardiac death. On 10Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient received BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN with unknown lot number) via an unknown route of administration as DOSE1, SINGLE for COVID-19 immunization at 14:30 on 09Jun2021. Anaphylactic reaction was not observed after the vaccination. Although the reporting pharmacist investigated the lot number of the vaccine, whether it was a Pfizer product or not was unknown. The vaccine the patient received could not be fully identified as a Pfizer product. The patient was recently confirmed to be alive at 03:00 by a family member. The patient was found to be losing his consciousness in a bathroom at 06:30 by a family member and an ambulance was requested. When the emergency medical staff arrived, the patient was in cardiac arrest. The emergency medical staff called an emergency call to the hospital and was instructed to conduct a specific treatment. Cardiac massage and other medical treatment must have been conducted until an emergency call was made to the hospital. At 07:30 on 10Jun2021, the patient arrived at the hospital. Cardiac arrest was confirmed. Although adrenaline (ADRENALINE) at 1 ampule was administered five times and fluid replacement of sodium bicarbonate (MEYLON) were administered, cardiac arrest was still observed without resurgence of heart rate. At 08:00, an explanation was given to the family member and the patient was confirmed dead. Due to unknown cause of death, autopsy imaging was performed. The result of autopsy imaging showed no life-threatening lesions in the skull. The influence of cardiac massage was observed in the chest, but the patient was being followed up because he visited the hospital regularly. According to autopsy findings, the patient tested negative for COVID-19 and died of acute cardiac disease. A death certificate was made and the patient was reported to have died at around 06:00. The reporting pharmacist classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were unknown. The reporting pharmacist''s comments: The reporting pharmacist reported this case considering it was necessary to provide information as the responsibility of the facility, though the patient received BNT162b2 at another facility in a local community center.; Sender''s Comments: Based on the close temporal relationship, the association between the event cardiac death with BNT162b2 can not be completely 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 death


VAERS ID: 1428861 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Body temperature, C-reactive protein, Clostridium test, Dehydration, Enterocolitis, Sepsis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:38 - 39 Centigrade; Test Date: 20210608; Test Name: Clostridium difficile toxin; Test Result: Negative ; Test Date: 20210608; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Date: 20210608; Test Name: WBC; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC2021682365

Write-up: Sepsis; acute enterocolitis; dehydration; acute renal failure; This is an initial spontaneous report from a contactable pharmacist received via a regulatory authority. The patient was a non-pregnant 77-year-old female. 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 cardiac failure chronic and rheumatoid arthritis chronic. On 04Jun2021 at 12:15 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm as DOSE 1, SINGLE for COVID-19 immunization, vaccinated at the hospital. On 05Jun2021 at 12:30 (1 day after the vaccination), the patient experienced sepsis. The event resulted in hospitalization and death. The reporter classified the event as serious (hospitalization and death). The patient was hospitalized for 6 days. The outcome of the event was fatal with treatment including fluid replacement, antibiotics, and ADRENALINE. The patient died on 10Jun2021. No information was provided whether autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. Follow-up (11Jun2021): This is a follow-up spontaneous report from the same contactable pharmacist received from a regulatory authority. Regulatory authority report number is v21113135. The patient was 77-year and 1-month-old (month was reported) female. Body temperature before vaccination was 36.7 degrees Centigrade. On 05Jun2021 at 12:35 (1 day after the vaccination) , the patient experienced sepsis. The reporting pharmacist assessed that the causality between sepsis and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac failure, acute enterocolitis, dehydration, and acute renal failure. The clinical course of treatment was as follows; On 04Jun2021, the patient received BNT162b2 (COMIRNATY). On 05Jun2021, the patient had pyrexia of 38 to 39 degrees centigrade range. Findings for pneumonia, urinary tract infection, and inflammatory of joints of four extremities were not noted. On 06Jun2021, the patient had inappetence. Considering dehydration, fluid replacement was performed. Around noon of 06Jun2021, the patient had feeling queasy, vomiting, and diarrhoea. As having cardiac failure congestive and rheumatoid arthritis, considering the risk of infection, she was given SBT/ABPC (Sulbactam / Ampicillin) 1.5 g via intravenous drip infusion from the evening of 07Jun2021. On 08Jun2021, the patient had large amount of diarrhoea, which she did not experience thereafter. Clostridium difficile toxin test was negative. Blood culture results would be available soon. WBC and CRP increased. Electrolyte abnormality was not observed. On 10Jun2021, just before 08:00, the patient''s condition changed abruptly and spontaneous respiration was stopped. In spite of cardiopulmonary resuscitation (CPR), she was confirmed to be dead at 09:08. The reporting pharmacist commented as follows; This was a patient with reduced reserve capacity such as having underlying diseases of cardiac disorder and rheumatoid arthritis as well as inappetence. Diarrhoea subsequent to pyrexia following vaccination with BNT162b2 produced dehydration, which was treated by fluid replacement. However, acute enterocolitis and sepsis developed; and the general condition became aggravated drastically, due to which the patient ran fatal outcome. The vaccine appeared to be indirect more than a direct cause.; Sender''s Comments: The evens considered intercurrent conditions and unrelated to suspect product BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EX3617; Expiration Date: 31Aug2021).; Reported Cause(s) of Death: Sepsis; Cardiac failure; Acute enterocolitis; Dehydration; Acute renal failure


VAERS ID: 1428867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021682589

Write-up: This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection, lot number: FA5715, expiration date: 31Aug2021), intramuscular in left arm on 08Jun2021 at 14:00 at dose 2, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). The patient received other medications (unspecified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included chronic kidney disease and maintenance dialysis. On 18May2021 at 14:00, the patient previously received the first single dose of BNT162B2 (COMIRNATY, lot number and expiration date were unknown), intramuscular in the left arm for COVID-19 immunization. On 08Jun2021 at 14:00 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FA5715, expiration date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 10Jun2021 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On the morning of 10Jun2021, the patient was found in a status of cardio-respiratory arrest. The patient was taken by ambulance. Heartbeat did not resume, and he was confirmed to be dead on the same day. No information was provided whether autopsy was performed. It was unknown as to whether treatment was done for the event. The event resulted in emergency room/department, urgent care, and death. The outcome of the event was fatal. The reporting physician commented that a clear causal relationship with the vaccine was not proven. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal association and currently known drug safety profile, the reported event cardio-respiratory arrest more likely represented intercurrent illness, but not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1428871 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Interstitial lung disease, Oxygen saturation, X-ray
SMQs:, Cardiac failure (narrow), Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2021-06-10
   Days after onset: 1
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: CARVEDILOL; TRAMCET; NAUZELIN; AMLODIN; BEOVA; THYRADIN; LASIX [FUROSEMIDE]; CLOPIDOGREL; YODEL; MAGNESIUM OXIDE; GOSHAJINKIGAN; LEVOCETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Atrial fibrillation; Cardiac failure chronic; Hypertension; Hypothyroidism; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210609; Test Name: SpO2; Test Result: 72 %; Test Date: 20210609; Test Name: X-ray; Result Unstructured Data: Test Result:cardiac failure; Comments: and shadow of interstitial pneumonia
CDC Split Type: JPPFIZER INC2021684448

Write-up: cardiac failure; interstitial pneumonia suspected; This is a spontaneous report from a contactable other health professional received via a Pfizer sales representative; a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21113620. The patient was a non-pregnant 92-year and 5-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received carvedilol (CARVEDILOL), paracetamol, tramadol hydrochloride (TRAMCET), domperidone (NAUZELIN), amlodipine besilate (AMLODIN), vibegron (BEOVA), thyroid (THYRADIN), furosemide (LASIX), clopidogrel, senna alexandrina (YODEL), magnesium oxide, achyranthes bidentata root, aconitum spp. processed root, alisma plantago-aquatica var. orient. tuber, cinnamomum cassia bark, cornus officinalis fruit, dioscorea spp. rhizome, paeonia x suffruticosa root bark, plantago asiatica seed, poria cocos sclerotium, rehmannia glutinosa root (GOSHAJINKIGAN), levocetirizine hydrochloride within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient has been told by her physician that she may receive the vaccination. The patient has not experienced any pyrexia or illness within the last 1 month. The patient did not feel sick on the day of vaccination. The patient had no history of convulsions (seizures). The patient had no history of severe allergic symptoms (anaphylaxis, etc.) to medications or foods. The patient has never been sick from a previous vaccination. The patient was not currently pregnant or breastfeeding, and had not received any other vaccinations within the past 2 weeks. Medical history included angina pectoris, hypertension, cardiac failure chronic, renal failure chronic, atrial fibrillation (AF) and hypothyroidism. On 08Jun2021 at 12:00 (the day of vaccination) at the age of 92-year-old, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular in the left arm at 0.3 mL for COVID-19 immunization. On 09Jun2021 at 9:00, the patient experienced cardiac failure (hospitalization, death), interstitial pneumonia suspected (hospitalization). Clinical course of the event was reported as follows: At around 9:00, sudden onset of dysponea and wheezing in taxi. The patient visit the reporter''s hospital and was started on oxygen inhalation. After that, the patient was emergency transported to another hospital. On 09Jun2021 (1 day after the vaccination), in the morning, the patient had shortness of breath. Therefore, the patient visited the reporter''s hospital where X-ray showed cardiac failure and shadow of interstitial pneumonia. SpO2 (oxygen saturation percutaneous) was 72%. After oxygen administration was performed, the patient was transferred to another hospital. Therefore, subsequent medical treatment was unknown. The patient was hospitalized for 2 days (09Jun2021 and 10Jun2021). The patient died on 10Jun2021. The cause of death was cardiac failure. It was uncertain if an autopsy was performed. The reporting physician classified the event cardiac failure as serious (death/hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac failure. The outcome of interstitial pneumonia suspected was unknown. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The causal association of the events cardiac failure and interstitial pneumonia in relation to suspected drug BNT162b2 cannot be totally excluded. Case will be reassessed pending new 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: 1428872 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Platelet count, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ascites; Dementia; Hypoproteinaemia; Intestinal pseudo-obstruction; Platelets decreased; Pleural effusion
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.0 Centigrade; Comments: before vaccination; Test Date: 20210607; Test Name: SpO2; Test Result: 98 %; Comments: at room air, at 14:30; Test Name: platelets; Result Unstructured Data: Test Result: decreased
CDC Split Type: JPPFIZER INC2021684480

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received via a regulatory authority and a other healthcare professional received from another regulatory authority. Regulatory authority report number is v21113307. The patient was a 79 years and 5 months old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received rivaroxaban (XARELTO) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was not reported as to whether the patient had allergies to medications, food, or other products. Body temperature before vaccination was 36.0 degrees Centigrade. Other medical history chronic idiopathic pseudointestinal obstruction, hypoproteinaemia, ascites retention, pleural effusion, and platelets decreased and dementia. On 07Jun2021 at 10:59 (the day of vaccination, at age of 79-year-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. Between 27May2021 (11 days before the vaccination) and 07Jun2021 (the day of the vaccination), the patient was hospitalized. On 07Jun2021 at 18:40, the patient experienced respiratory arrest. (However, it was also reported that the start time of the event was 18:45). The course of the event was as follows: There was no particular change immediately after the vaccination. The patient was an inpatient. It was a serious case (disseminated intravascular coagulation (DIC) onset case) that should not have been vaccinated in view of the general condition. The event resulted in hospitalization and death. The outcome of the events was fatal without treatment. Since the vaccination, the patient has not been tested for COVID-19. The patient died of disseminated intravascular coagulation syndrome on 07Jun2021. An autopsy was not performed. At 14:30 (4 hours and 31 minutes after the vaccination), SpO2 was 98% (room air). At 18:40 (7 hours and 41 minutes after the vaccination), a nurse found that the patient was in respiratory arrest. The nurse contacted a duty doctor and the patient''s death was confirmed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was disseminated intravascular coagulation syndrome. The reporting physician commented as follows: The report on examination (platelets decreased) had not been confirmed before the vaccination.; Reported Cause(s) of Death: Disseminated intravascular coagulation syndrome


VAERS ID: 1428880 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial rupture, Blood creatine phosphokinase, Blood pressure measurement, Cardiac death, Cardio-respiratory arrest, Coma scale, Computerised tomogram, Electrocardiogram, Investigation, Malaise, Muscle enzyme, Nausea, Oxygen saturation, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: CK; Result Unstructured Data: Test Result:420; Test Date: 20210609; Test Name: BP; Result Unstructured Data: Test Result:76/41; Test Date: 20210609; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210609; Test Name: Systemic CT; Result Unstructured Data: Test Result:thoracic aortic aneurysm (double-layered); Comments: pericardial fluid (cardiac tamponade) in right thoracic cavity, significant coronary artery calcification; Test Date: 20210609; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:waveform of pulseless electrical activity (PEA); Test Date: 20210609; Test Name: Heart type fatty acid-binding protein (H-FABP); Test Result: Positive ; Test Date: 20210609; Test Name: muscle enzyme; Result Unstructured Data: Test Result:increased; Test Date: 20210609; Test Name: PSPO2; Test Result: 41 %; Test Date: 20210609; Test Name: TROP T (cardiac troponin); Test Result: Positive
CDC Split Type: JPPFIZER INC2021684849

Write-up: Acute cardiac death; Acute thoracic arterial rupture; cardiopulmonary arrest (CPA); malaise; Queasy; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). This is a report received from the regulatory authority. Regulatory authority report number is v21113295. An 80-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jun2021 at a single dose for covid-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Medical history included thoracic aortic aneurysm. The patient had no family history. The patient''s concomitant medications were not reported. On 08Jun2021, the patient experienced queasy. On 09Jun2021 at 20:57, the patient experienced acute cardiac death and acute thoracic arterial rupture, which were serious for death. On 09Jun2021, the patient experienced cardiopulmonary arrest (CPA), which was fatal and malaise. The events, queasy and malaise, required emergency room visit. The clinical course was as follows: on 08Jun2021 (the day of vaccination), the patient received single dose of BNT162b2. On 09Jun2021 at 21:00 (1 day after the vaccination), the patient experienced acute cardiac death and acute thoracic arterial rupture. The outcome of the event was fatal, it was unknown if the treatment was provided. No autopsy was performed. Death cause was provided as acute thoracic arterial rupture. The reporting pharmacist assessed the events as serious (Death). It was unknown if the patient has not been tested for COVID-19 since the vaccination. The onset time of the events was updated from 21:00 to 20:57. Event course was provided: on 08Jun2021 (the day of vaccination), the patient received BNT162b2 vaccine (Lot No. and Expiration date unknown). Queasy persisted from nighttime. On 09Jun2021 (1 day after the vaccination), malaise aggravated but no chest pain was noted. At 19:00, the patient had conversation with her eldest son. The eldest son was aware at 20:57 and called the emergency service. On arrival of the emergency squad, coma scale (CS) was 300, cardiopulmonary arrest (CPA) was noted, and electrocardiographic waveform was pulseless electrical activity (PEA). Esophageal intubation was performed with laryngeal tube No. 3, and the patient was arrived at the hospital at 21:25 warring bag valve mask (BVM). BP 76/41, PSPO2 41%. At 21:44, 10L of oxygen was started. Blood was collected from inguinal region. Systemic CT was performed. At 23:03, death of the patient was confirmed. Muscle enzyme increased, thoracic aortic aneurysm (double-layered), pericardial fluid (cardiac tamponade) in right thoracic cavity, significant coronary artery calcification, CK 420, TROP T (cardiac troponin) positive, heart type fatty acid-binding protein (H-FABP) positive. The clinical outcome of the events, queasy and malaise, was unknown. The patient died on 09Jun2021 at 23:03 due to acute cardiac death, acute thoracic arterial rupture, and cardiopulmonary arrest (CPA). An autopsy was not performed. The reporting pharmacist considered the causality between the event sand BNT162b2 as unassessable. Other possible cause of the events such as any other diseases was thoracic aortic aneurysm. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute thoracic arterial rupture; Acute cardiac death; cardiopulmonary arrest (CPA)


VAERS ID: 1428881 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Cardio-respiratory arrest, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Hypoxic-ischaemic encephalopathy, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: abdomen CT; Result Unstructured Data: Test Result:aspiration materiol in the tracheal; Test Date: 20210603; Test Name: Head CT; Result Unstructured Data: Test Result:coronary artery calcification; Test Date: 20210603; Test Name: chest CT; Result Unstructured Data: Test Result:aspiration material in the tracheal
CDC Split Type: JPPFIZER INC2021684901

Write-up: vomiting; asphyxia; hypoxic encephalopathy; Cardio-respiratory arrest; A 90-year and 1-month-old female patient received 2nd dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: EY5420, expiration date: 31Aug2021) via an unspecified route of administration on 01Jun2021 at age of 90-year-old at single dose for COVID-19 immunisation. Medical history included heart disease. Body temperature on 01Jun2021 before vaccination was 36.5 degrees Centigrade. Concomitant medications included oral warfarin potassium (WARFARIN). Family history was not provided. 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 03Jun2021 at 18:00 (2 days after the vaccination), the patient developed vomiting, asphyxia and hypoxic encephalopathy and she was hospitalized. Consciousness decreased was present on that day. On 04Jun2021 at 06:30 (3 days after the vaccination), the patient died. The cause of death was suspected to be vomiting, asphyxia and hypoxic encephalopathy. It was not reported if an autopsy was performed. The course of the events was as follows: On 03Jun2021 at around 18:00, the patient had dinner and then took oral medicine and received inhalation therapy. Afterwards, she vomited. Consciousness decreased was present. An emergency service was requested. While transferring to the reporter''s hospital, resuscitation was performed. When tracheal intubation was performed, there was a large amount of food residue inside the mouth. Head CT, chest CT and abdomen CT indicated aspiration material in the trachea, and coronary artery calcification. After the procedures, spontaneous circulation was returned. The patient was hospitalized. On 04Jun2021 at 05:22, the patient developed cardio-respiratory arrest. On 04Jun2021 at 06:30, the patient''s death was confirmed. The reporting physician classified the events as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as un-assessable. It was not reported if there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: It was suspected that the patient died caused by vomiting, asphyxia and hypoxic encephalopathy due to vomiting and asphyxia.; Reported Cause(s) of Death: Cardio-respiratory arrest; vomiting; asphyxia; hypoxic encephalopathy


VAERS ID: 1428882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Electrocardiogram, Feeling abnormal, Loss of consciousness, Malaise, Respiratory rate decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Initial waveform at visit; Result Unstructured Data: Test Result:Asystole
CDC Split Type: JPPFIZER INC2021684905

Write-up: Death/unnatural death; He was unconscious; A decline in the respiratory condition; Patient said he felt dull; Malaise; The initial waveform at visit was asystole; This is a spontaneous report from a contactable Health Care Professional received from a regulatory authority. Regulatory authority report number is v21112966. The patient was a 77-year-old male. Body temperature before vaccination, family history, medical history, and 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): details were unknown. On an unknown date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number unknown, Expiration date unknown) at single dose, for COVID-19 immunisation. On 08Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration, at single dose, for COVID-19 immunisation. On 10Jun2021 at 08:00 (2 days after the vaccination), the patient experienced malaise. On 10Jun2021 around 08:30 (2 days after the vaccination), the patient experienced unconscious and a decline in the respiratory condition. On 10Jun2021 at 09:08 (2 days after the vaccination), the patient experienced death/unnatural death. The outcome of the reporting event of malaise was fatal (as reported). It was unknown if autopsy was done. The course of the events was as follows: on 08Jun2021 (the day of vaccination), the patient was vaccinated by the visiting physician. On 09Jun2021, the patient spent the day without notable pyrexia. On 10Jun2021 at 08:00, the patient ate about 10% of his breakfast. The patient said he felt dull and went back to his room. Around 08:30, the staff checked the patient''s condition, and he was unconscious with a decline in the respiratory condition; an ambulance was called. Chest compression and mask ventilation were performed until reaching the destination, but the initial waveform at visit was asystole. Thereafter, a confirmation was made that the family did not wish for resuscitation, and resuscitation was terminated. At 09:08, death confirmation was performed, and a contact was made to the police station that had the jurisdiction as it was an unnatural death. The reporting Health Care Professional assessed the causality between the event and BNT162B2 as unassessable. The seriousness and causality of the other events were not reported. Other possible cause(s) of the events such as any other diseases was unknown. The reporting Health Care Professional commented as follows: no death certificate was made at our hospital as we confirmed that the police station would perform the autopsy. Death confirmation was performed at our hospital, but the degree of the symptoms was assessed as unassessable.; Reported Cause(s) of Death: Unknown cause of death; Malaise


VAERS ID: 1428903 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Altered state of consciousness, Amylase, Anisocytosis, Arthralgia, Aspartate aminotransferase, Band neutrophil count, Basophil count, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood cholesterol, Blood cholinesterase, Blood creatine phosphokinase, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood test, Blood triglycerides, Blood urea, Blood uric acid, Body temperature, Brain natriuretic peptide, C-reactive protein, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Cerebral infarction, Computerised tomogram, Dyspnoea, Electrocardiogram, Eosinophil count, Eye movement disorder, Full blood count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haematology test, Haemoglobin, Hepatitis B surface antigen, Hepatitis C virus test, High density lipoprotein, Investigation, KL-6, LDL/HDL ratio, Legionella test, Leukocyte alkaline phosphatase, Low density lipoprotein, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Metamyelocyte count, Monocyte count, Neutrophil count, Non-high-density lipoprotein cholesterol, Platelet count, Pneumonia, Prostatic specific antigen, Protein total, Red blood cell analysis, Red blood cell count, Red cell distribution width, Reticulocyte count, SARS-CoV-2 test, Streptococcus test, Taste disorder, Total bile acids, Urinary sediment, Urine analysis, White blood cell analysis, White blood cell count
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 26 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: REBAMIPIDE; PARIET; PANALDINE; XYZAL; AVOLVE; ZACRAS; SHAKUYAKUKANZOTO; SENNOSIDE A+B; FEXOFENADINE; CELECOX; HARNAL; CALONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Hyperuricaemia; Old cerebral infarction; Prostatic hyperplasia; Reflux oesophagitis; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Baso #; Result Unstructured Data: Test Result:0.04; Test Date: 20210517; Test Name: Baso #; Result Unstructured Data: Test Result:0.06; Test Date: 20210520; Test Name: Baso #; Result Unstructured Data: Test Result:0.05; Test Date: 20210524; Test Name: Baso #; Result Unstructured Data: Test Result:0.04; Test Date: 20210527; Test Name: Baso #; Result Unstructured Data: Test Result:0.01; Test Date: 20210531; Test Name: Baso #; Result Unstructured Data: Test Result:0.04; Test Date: 20210507; Test Name: Baso %; Test Result: 0.4 %; Test Date: 20210511; Test Name: Baso %; Test Result: 0.7 %; Test Date: 20210514; Test Name: Baso %; Test Result: 0.4 %; Test Date: 20210517; Test Name: Baso %; Test Result: 0.4 %; Test Date: 20210520; Test Name: Baso %; Test Result: 0.2 %; Test Date: 20210524; Test Name: Baso %; Test Result: 0.3 %; Test Date: 20210527; Test Name: Baso %; Test Result: 0.1 %; Test Date: 20210531; Test Name: Baso %; Test Result: 0.2 %; Test Date: 20210507; Test Name: D-BIL; Result Unstructured Data: Test Result:0.14; Test Date: 20210507; Test Name: ALB; Result Unstructured Data: Test Result:2.3 L; Test Date: 20210514; Test Name: ALB; Result Unstructured Data: Test Result:2.0 L; Test Date: 20210520; Test Name: ALB; Result Unstructured Data: Test Result:2.0 L; Test Date: 20210527; Test Name: ALB; Result Unstructured Data: Test Result:2.3 L; Test Date: 20210507; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:122 H; Test Date: 20210514; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:95; Test Date: 20210520; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:94; Test Date: 20210527; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:60; Test Date: 20210507; Test Name: T-BIL; Result Unstructured Data: Test Result:0.56; Test Date: 20210514; Test Name: T-BIL; Result Unstructured Data: Test Result:0.42; Test Date: 20210520; Test Name: T-BIL; Result Unstructured Data: Test Result:0.36; Test Date: 20210527; Test Name: T-BIL; Result Unstructured Data: Test Result:0.35; Test Date: 20210507; Test Name: CI; Result Unstructured Data: Test Result:102; Test Date: 20210511; Test Name: CI; Result Unstructured Data: Test Result:102; Test Date: 20210514; Test Name: CI; Result Unstructured Data: Test Result:102; Test Date: 20210517; Test Name: CI; Result Unstructured Data: Test Result:103; Test Date: 20210520; Test Name: CI; Result Unstructured Data: Test Result:101; Test Date: 20210524; Test Name: CI; Result Unstructured Data: Test Result:97 L; Test Date: 20210527; Test Name: CI; Result Unstructured Data: Test Result:105; Test Date: 20210531; Test Name: CI; Result Unstructured Data: Test Result:108; Test Date: 20210507; Test Name: T-CHO; Result Unstructured Data: Test Result:162; Test Date: 20210507; Test Name: CHE; Result Unstructured Data: Test Result:140 L; Test Date: 20210507; Test Name: CPK; Result Unstructured Data: Test Result:28 L; Test Date: 20210514; Test Name: CPK; Result Unstructured Data: Test Result:21 L; Test Date: 20210520; Test Name: CPK; Result Unstructured Data: Test Result:83; Test Date: 20210527; Test Name: CPK; Result Unstructured Data: Test Result:26 L; Test Date: 20210507; Test Name: CRE; Result Unstructured Data: Test Result:0.68; Test Date: 20210511; Test Name: CRE; Result Unstructured Data: Test Result:0.66; Test Date: 20210514; Test Name: CRE; Result Unstructured Data: Test Result:0.68; Test Date: 20210517; Test Name: CRE; Result Unstructured Data: Test Result:0.84; Test Date: 20210520; Test Name: CRE; Result Unstructured Data: Test Result:0.95; Test Date: 20210524; Test Name: CRE; Result Unstructured Data: Test Result:0.76; Test Date: 20210527; Test Name: CRE; Result Unstructured Data: Test Result:0.59 L; Test Date: 20210531; Test Name: CRE; Result Unstructured Data: Test Result:0.72; Test Date: 20210531; Test Name: ABG 02Hb; Result Unstructured Data: Test Result:86.9; Test Date: 20210531; Test Name: ABG BE (vt); Result Unstructured Data: Test Result:-1.9; Test Date: 20210531; Test Name: ABG BE (vv); Result Unstructured Data: Test Result:0.0; Test Date: 20210531; Test Name: ABG C0Hb; Result Unstructured Data: Test Result:2.0; Test Date: 20210531; Test Name: ABG Ca++; Result Unstructured Data: Test Result:1.17; Test Date: 20210531; Test Name: ABG Ca++ corrected; Result Unstructured Data: Test Result:1.08; Test Date: 20210531; Test Name: ABG CI; Result Unstructured Data: Test Result:99; Test Date: 20210531; Test Name: ABG GLU; Result Unstructured Data: Test Result:148 H; Test Date: 20210531; Test Name: ABG HC03-a; Result Unstructured Data: Test Result:27.9; Test Date: 20210531; Test Name: ABG HC03-s; Result Unstructured Data: Test Result:22.7 L; Test Date: 20210531; Test Name: ABG HHb; Result Unstructured Data: Test Result:10.8; Test Date: 20210531; Test Name: ABG K; Result Unstructured Data: Test Result:4.85; Test Date: 20210531; Test Name: ABG MetHb; Result Unstructured Data: Test Result:0.3; Test Date: 20210531; Test Name: ABG Na; Result Unstructured Data: Test Result:136.2 L; Test Date: 20210531; Test Name: ABG P02; Result Unstructured Data: Test Result:66.4 L; Test Date: 20210531; Test Name: ABG PC02; Result Unstructured Data: Test Result:71.3 H; Test Date: 20210531; Test Name: ABG pH; Result Unstructured Data: Test Result:7.210 L; Test Date: 20210531; Test Name: ABG S02; Result Unstructured Data: Test Result:88.9; Test Date: 20210531; Test Name: ABG tC02; Result Unstructured Data: Test Result:30.1 H; Test Date: 20210531; Test Name: ABG tHb; Result Unstructured Data: Test Result:14.6; Test Date: 20210531; Test Name: ABGAnGap+K; Result Unstructured Data: Test Result:14.2; Test Date: 20210531; Test Name: ABGAnGap-K; Result Unstructured Data: Test Result:14.2 H; Test Date: 20210507; Test Name: Blood sugar; Result Unstructured Data: Test Result:223 H; Test Date: 20210507; Test Name: GLU; Result Unstructured Data: Test Result:223 H; Test Date: 20210507; Test Name: LDH (IFCC); Result Unstructured Data: Test Result:160; Test Date: 20210514; Test Name: LDH (IFCC); Result Unstructured Data: Test Result:165; Test Date: 20210520; Test Name: LDH (IFCC); Result Unstructured Data: Test Result:251 H; Test Date: 20210527; Test Name: LDH (IFCC); Result Unstructured Data: Test Result:148; Test Date: 20210507; Test Name: K; Result Unstructured Data: Test Result:3.7; Test Date: 20210511; Test Name: K; Result Unstructured Data: Test Result:4.0; Test Date: 20210514; Test Name: K; Result Unstructured Data: Test Result:4.2; Test Date: 20210517; Test Name: K; Result Unstructured Data: Test Result:4.3; Test Date: 20210507; Test Name: ALT (GPT); Result Unstructured Data: Test Result:8; Test Date: 20210514; Test Name: ALT (GPT); Result Unstructured Data: Test Result:11; Test Date: 20210520; Test Name: ALT (GPT); Result Unstructured Data: Test Result:24; Test Date: 20210527; Test Name: ALT (GPT); Result Unstructured Data: Test Result:11; Test Date: 20210507; Test Name: A/G; Result Unstructured Data: Test Result:0.56 L; Test Date: 20210514; Test Name: A/G; Result Unstructured Data: Test Result:0.50 L; Test Date: 20210520; Test Name: A/G; Result Unstructured Data: Test Result:0.47 L; Test Date: 20210527; Test Name: A/G; Result Unstructured Data: Test Result:0.77 L; Test Date: 20210507; Test Name: AMY; Result Unstructured Data: Test Result:49; Test Date: 20210531; Test Name: ANISO; Result Unstructured Data: Test Result:+; Test Date: 20210507; Test Name: AST (GOT); Result Unstructured Data: Test Result:11 L; Test Date: 20210514; Test Name: AST (GOT); Result Unstructured Data: Test Result:13; Test Date: 20210520; Test Name: AST (GOT); Result Unstructured Data: Test Result:53 H; Test Date: 20210527; Test Name: AST (GOT); Result Unstructured Data: Test Result:15; Test Date: 20210531; Test Name: Stab; Result Unstructured Data: Test Result:2; Test Date: 20210507; Test Name: Baso #; Result Unstructured Data: Test Result:0.04; Test Date: 20210511; Test Name: Baso #; Result Unstructured Data: Test Result:0.06; Test Date: 20210520; Test Name: K; Result Unstructured Data: Test Result:4.6; Test Date: 20210524; Test Name: K; Result Unstructured Data: Test Result:4.6; Test Date: 20210527; Test Name: K; Result Unstructured Data: Test Result:5.3 H; Test Date: 20210531; Test Name: K; Result Unstructured Data: Test Result:6.2 H; Test Date: 20210507; Test Name: Na; Result Unstructured Data: Test Result:139; Test Date: 20210511; Test Name: Na; Result Unstructured Data: Test Result:136 L; Test Date: 20210514; Test Name: Na; Result Unstructured Data: Test Result:136 L; Test Date: 20210517; Test Name: Na; Result Unstructured Data: Test Result:137 L; Test Date: 20210520; Test Name: Na; Result Unstructured Data: Test Result:138; Test Date: 20210524; Test Name: Na; Result Unstructured Data: Test Result:139; Test Date: 20210527; Test Name: Na; Result Unstructured Data: Test Result:153 H; Test Date: 20210531; Test Name: Na; Result Unstructured Data: Test Result:150 H; Test Date: 20210531; Test Name: LPLT; Result Unstructured Data: Test Result:+; Test Date: 20210507; Test Name: LUC #; Result Unstructured Data: Test Result:0.07; Test Date: 20210511; Test Name: LUC #; Result Unstructured Data: Test Result:0.10; Test Date: 20210514; Test Name: LUC #; Result Unstructured Data: Test Result:0.06; Test Date: 20210517; Test Name: LUC #; Result Unstructured Data: Test Result:0.09; Test Date: 20210520; Test Name: LUC #; Result Unstructured Data: Test Result:0.11; Test Date: 20210524; Test Name: LUC #; Result Unstructured Data: Test Result:0.16; Test Date: 20210527; Test Name: LUC #; Result Unstructured Data: Test Result:0.09; Test Date: 20210531; Test Name: LUC #; Result Unstructured Data: Test Result:0.12; Test Date: 20210507; Test Name: LUC %; Test Result: 0.8 %; Test Date: 20210511; Test Name: LUC %; Test Result: 1.2 %; Test Date: 20210514; Test Name: LUC %; Test Result: 0.7 %; Test Date: 20210517; Test Name: LUC %; Test Result: 0.7 %; Test Date: 20210520; Test Name: LUC %; Test Result: 0.4 %; Test Date: 20210524; Test Name: LUC %; Test Result: 1.2 %; Test Date: 20210527; Test Name: LUC %; Test Result: 0.7 %; Test Date: 20210531; Test Name: LUC %; Test Result: 0.5 %; Test Date: 20210507; Test Name: TG; Result Unstructured Data: Test Result:97; Test Date: 20210507; Test Name: BUN; Result Unstructured Data: Test Result:16.9; Test Date: 20210511; Test Name: BUN; Result Unstructured Data: Test Result:7.6 L; Test Date: 20210514; Test Name: BUN; Result Unstructured Data: Test Result:11.2; Test Date: 20210517; Test Name: BUN; Result Unstructured Data: Test Result:12.3; Test Date: 20210520; Test Name: BUN; Result Unstructured Data: Test Result:25.5 H; Test Date: 20210524; Test Name: BUN; Result Unstructured Data: Test Result:36.4 H; Test Date: 20210527; Test Name: BUN; Result Unstructured Data: Test Result:32.1 H; Test Date: 20210531; Test Name: BUN; Result Unstructured Data: Test Result:27.4 H; Test Date: 20210507; Test Name: UA; Result Unstructured Data: Test Result:4.6; Test Date: 20210428; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210507; Test Name: BNP; Result Unstructured Data: Test Result:42.9 H; Test Date: 20210507; Test Name: CA19-9; Result Unstructured Data: Test Result:lower than 2.00; Test Date: 20210507; Test Name: CEA; Result Unstructured Data: Test Result:5.6 H; Test Date: 20210531; Test Name: CT from the head through the trunk; Result Unstructured Data: Test Result:revealed no apparent abnormal findings in the head; Test Date: 20210507; Test Name: CRP; Result Unstructured Data: Test Result:18.24 H; Test Date: 20210511; Test Name: CRP; Result Unstructured Data: Test Result:13.28 H; Test Date: 20210514; Test Name: CRP; Result Unstructured Data: Test Result:19.15 H; Test Date: 20210517; Test Name: CRP; Result Unstructured Data: Test Result:22.85 H; Test Date: 20210520; Test Name: CRP; Result Unstructured Data: Test Result:13.62 H; Test Date: 20210524; Test Name: CRP; Result Unstructured Data: Test Result:2.70 H; Test Date: 20210527; Test Name: CRP; Result Unstructured Data: Test Result:1.28 H; Test Date: 20210531; Test Name: CRP; Result Unstructured Data: Test Result:1.44 H; Test Date: 20210507; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:result unknown; Test Date: 20210520; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:result unknown; Test Date: 20210507; Test Name: Eos; Result Unstructured Data: Test Result:12 H; Test Date: 20210514; Test Name: Eos; Result Unstructured Data: Test Result:20 H; Test Date: 20210517; Test Name: Eos; Result Unstructured Data: Test Result:5; Test Date: 20210531; Test Name: Eos; Result Unstructured Data: Test Result:1; Test Date: 20210507; Test Name: Eos #; Result Unstructured Data: Test Result:1.04 H; Test Date: 20210511; Test Name: Eos #; Result Unstructured Data: Test Result:1.01 H; Test Date: 20210514; Test Name: Eos #; Result Unstructured Data: Test Result:1.32 H; Test Date: 20210517; Test Name: Eos #; Result Unstructured Data: Test Result:0.86 H; Test Date: 20210520; Test Name: Eos #; Result Unstructured Data: Test Result:0.10; Test Date: 20210524; Test Name: Eos #; Result Unstructured Data: Test Result:0.03; Test Date: 20210527; Test Name: Eos #; Result Unstructured Data: Test Result:0.03; Test Date: 20210531; Test Name: Eos #; Result Unstructured Data: Test Result:0.02 H; Test Date: 20210507; Test Name: Eos %; Result Unstructured Data: Test Result:11.7 H %; Test Date: 20210511; Test Name: Eos %; Result Unstructured Data: Test Result:12.5 H %; Test Date: 20210514; Test Name: Eos %; Result Unstructured Data: Test Result:14.3 H %; Test Date: 20210517; Test Name: Eos %; Test Result: 6.5 %; Test Date: 20210520; Test Name: Eos %; Test Result: 0.4 %; Test Date: 20210524; Test Name: Eos %; Test Result: 0.2 %; Test Date: 20210527; Test Name: Eos %; Test Result: 0.2 %; Test Date: 20210531; Test Name: Eos %; Test Result: 0.1 %; Test Date: 20210507; Test Name: CBC comment #1; Result Unstructured Data: Test Result:large platelets; Test Date: 20210514; Test Name: CBC comment #1; Result Unstructured Data: Test Result:large platelets; Test Date: 20210531; Test Name: CBC comment #1; Result Unstructured Data: Test Result:large platelets; Test Date: 20210507; Test Name: CBC comment #2; Result Unstructured Data: Test Result:PLT granulocyte anisocytosis; Test Date: 20210507; Test Name: G-GT; Result Unstructured Data: Test Result:17; Test Date: 20210514; Test Name: G-GT; Result Unstructured Data: Test Result:16; Test Date: 20210520; Test Name: G-GT; Result Unstructured Data: Test Result:22; Test Date: 20210527; Test Name: G-GT; Result Unstructured Data: Test Result:24; Test Date: 20210507; Test Name: eGFR; Result Unstructured Data: Test Result:80.6 L; Test Date: 20210511; Test Name: eGFR; Result Unstructured Data: Test Result:83.2 L; Test Date: 20210514; Test Name: eGFR; Result Unstructured Data: Test Result:80.6 L; Test Date: 20210517; Test Name: eGFR; Result Unstructured Data: Test Result:63.9 L; Test Date: 20210520; Test Name: eGFR; Result Unstructured Data: Test Result:55.9 L; Test Date: 20210524; Test Name: eGFR; Result Unstructured Data: Test Result:71.3 L; Test Date: 20210527; Test Name: eGFR; Result Unstructured Data: Test Result:94.1; Test Date: 20210531; Test Name: eGFR; Result Unstructured Data: Test Result:75.7 L; Test Date: 20210507; Test Name: HCT; Result Unstructured Data: Test Result:38.1 L; Test Date: 20210514; Test Name: HCT; Result Unstructured Data: Test Result:32.6; Test Date: 20210517; Test Name: HCT; Result Unstructured Data: Test Result:33.7 L; Test Date: 20210520; Test Name: HCT; Result Unstructured Data: Test Result:40.1; Test Date: 20210524; Test Name: HCT; Result Unstructured Data: Test Result:40.6; Test Date: 20210527; Test Name: HCT; Result Unstructured Data: Test Result:43.0; Test Date: 20210531; Test Name: HCT; Result Unstructured Data: Test Result:50.7 L; Test Date: 20210507; Test Name: Advia; Result Unstructured Data: Test Result:unknown results; Comments: request at 13:30 results at 13:31; Test Date: 20210524; Test Name: Advia; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:33 results at 08:34; Test Date: 20210527; Test Name: Advia; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:40 results at 08:42; Test Date: 20210531; Test Name: Advia; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:44 results at 08:45; Test Date: 20210507; Test Name: Hgb; Result Unstructured Data: Test Result:12.0 L; Test Date: 20210514; Test Name: Hgb; Result Unstructured Data: Test Result:10.3 L; Test Date: 20210517; Test Name: Hgb; Result Unstructured Data: Test Result:10.8 L; Test Date: 20210520; Test Name: Hgb; Result Unstructured Data: Test Result:12.4 L; Test Date: 20210524; Test Name: Hgb; Result Unstructured Data: Test Result:11.9 L; Test Date: 20210527; Test Name: Hgb; Result Unstructured Data: Test Result:12.6 L; Test Date: 20210531; Test Name: Hgb; Result Unstructured Data: Test Result:15.2; Test Date: 20210507; Test Name: HBs-Ag; Result Unstructured Data: Test Result:0.00; Test Date: 20210507; Test Name: HBsAg quantitative; Result Unstructured Data: Test Result:(-); Test Date: 20210507; Test Name: HCVAb quantitative; Result Unstructured Data: Test Result:(-); Test Date: 20210507; Test Name: HVC-Ab; Result Unstructured Data: Test Result:0.08; Test Date: 20210507; Test Name: HDL-C; Result Unstructured Data: Test Result:32 L; Test Date: 20210507; Test Name: ARCHITECT; Result Unstructured Data: Test Result:unknown results; Comments: request at 13:35 results at 13:51; Test Date: 20210507; Test Name: GA08; Result Unstructured Data: Test Result:unknown results; Comments: results at 13:32; Test Date: 20210527; Test Name: Rapid results; Result Unstructured Data: Test Result:unknown results; Comments: at 08:31; Test Date: 20210527; Test Name: KL-6; Result Unstructured Data: Test Result:272; Test Date: 20210507; Test Name: LDL/HDL ratio; Result Unstructured Data: Test Result:3.3 H; Test Date: 20210518; Test Name: Urinary legionella; Result Unstructured Data: Test Result:(-); Test Date: 20210507; Test Name: LAP; Result Unstructured Data: Test Result:36; Test Date: 20210507; Test Name: LDL-C; Result Unstructured Data: Test Result:107; Test Date: 20210507; Test Name: Lymp; Result Unstructured Data: Test Result:11 L; Test Date: 20210514; Test Name: Lymp; Result Unstructured Data: Test Result:8 L; Test Date: 20210517; Test Name: Lymp; Result Unstructured Data: Test Result:7 L; Test Date: 20210520; Test Name: Lymp; Result Unstructured Data: Test Result:6 L; Test Date: 20210531; Test Name: Lymp; Result Unstructured Data: Test Result:2 L; Test Date: 20210507; Test Name: Lymp #; Result Unstructured Data: Test Result:0.87 L; Test Date: 20210511; Test Name: Lymp #; Result Unstructured Data: Test Result:0.75 L; Test Date: 20210514; Test Name: Lymp #; Result Unstructured Data: Test Result:0.75 L; Test Date: 20210517; Test Name: Lymp #; Result Unstructured Data: Test Result:0.91 L; Test Date: 20210520; Test Name: Lymp #; Result Unstructured Data: Test Result:1.22; Test Date: 20210524; Test Name: Lymp #; Result Unstructured Data: Test Result:1.27; Test Date: 20210527; Test Name: Lymp #; Result Unstructured Data: Test Result:1.37; Test Date: 20210531; Test Name: Lymp #; Result Unstructured Data: Test Result:0.74 L; Test Date: 20210507; Test Name: Lymp %; Result Unstructured Data: Test Result:9.8 L %; Test Date: 20210511; Test Name: Lymp %; Result Unstructured Data: Test Result:9.3 L %; Test Date: 20210514; Test Name: Lymp %; Result Unstructured Data: Test Result:8.1 L %; Test Date: 20210517; Test Name: Lymp %; Result Unstructured Data: Test Result:6.9 L %; Test Date: 20210520; Test Name: Lymp %; Result Unstructured Data: Test Result:5.0 L %; Test Date: 20210524; Test Name: Lymp %; Result Unstructured Data: Test Result:9.5 L %; Test Date: 20210527; Test Name: Lymp %; Result Unstructured Data: Test Result:10.3 L %; Test Date: 20210531; Test Name: Lymp %; Result Unstructured Data: Test Result:3.0 L %; Test Date: 20210507; Test Name: MCH; Result Unstructured Data: Test Result:28.6; Test Date: 20210514; Test Name: MCH; Result Unstructured Data: Test Result:28.3; Test Date: 20210517; Test Name: MCH; Result Unstructured Data: Test Result:28.7; Test Date: 20210520; Test Name: MCH; Result Unstructured Data: Test Result:28.0; Test Date: 20210524; Test Name: MCH; Result Unstructured Data: Test Result:27.8 L; Test Date: 20210527; Test Name: MCH; Result Unstructured Data: Test Result:27.7 L; Test Date: 20210531; Test Name: MCH; Result Unstructured Data: Test Result:28.1; Test Date: 20210507; Test Name: MCHC; Result Unstructured Data: Test Result:31.5 L; Test Date: 20210514; Test Name: MCHC; Result Unstructured Data: Test Result:31.7 L; Test Date: 20210517; Test Name: MCHC; Result Unstructured Data: Test Result:32.2; Test Date: 20210520; Test Name: MCHC; Result Unstructured Data: Test Result:30.9 L; Test Date: 20210524; Test Name: MCHC; Result Unstructured Data: Test Result:29.4 L; Test Date: 20210527; Test Name: MCHC; Result Unstructured Data: Test Result:29.2 L; Test Date: 20210531; Test Name: MCHC; Result Unstructured Data: Test Result:29.9 L; Test Date: 20210507; Test Name: MCV; Result Unstructured Data: Test Result:90.8; Test Date: 20210514; Test Name: MCV; Result Unstructured Data: Test Result:89.6; Test Date: 20210517; Test Name: MCV; Result Unstructured Data: Test Result:89.3; Test Date: 20210520; Test Name: MCV; Result Unstructured Data: Test Result:90.4; Test Date: 20210524; Test Name: MCV; Result Unstructured Data: Test Result:94.8; Test Date: 20210527; Test Name: MCV; Result Unstructured Data: Test Result:95.0; Test Date: 20210531; Test Name: MCV; Result Unstructured Data: Test Result:93.9; Test Date: 20210507; Test Name: Meta; Result Unstructured Data: Test Result:1; Test Date: 20210520; Test Name: Meta; Result Unstructured Data: Test Result:1; Test Date: 20210507; Test Name: Mono; Result Unstructured Data: Test Result:2; Test Date: 20210514; Test Name: Mono; Result Unstructured Data: Test Result:7; Test Date: 20210517; Test Name: Mono; Result Unstructured Data: Test Result:8; Test Date: 20210520; Test Name: Mono; Result Unstructured Data: Test Result:4; Test Date: 20210531; Test Name: Mono; Result Unstructured Data: Test Result:4; Test Date: 20210507; Test Name: Mono #; Result Unstructured Data: Test Result:0.31; Test Date: 20210511; Test Name: Mono #; Result Unstructured Data: Test Result:0.55; Test Date: 20210514; Test Name: Mono #; Result Unstructured Data: Test Result:0.64; Test Date: 20210517; Test Name: Mono #; Result Unstructured Data: Test Result:0.61; Test Date: 20210520; Test Name: Mono #; Result Unstructured Data: Test Result:0.89; Test Date: 20210524; Test Name: Mono #; Result Unstructured Data: Test Result:1.00; Test Date: 20210527; Test Name: Mono #; Result Unstructured Data: Test Result:0.60; Test Date: 20210531; Test Name: Mono #; Result Unstructured Data: Test Result:0.93; Test Date: 20210507; Test Name: Mono %; Test Result: 3.5 %; Test Date: 20210511; Test Name: Mono %; Test Result: 6.8 %; Test Date: 20210514; Test Name: Mono %; Test Result: 6.9 %; Test Date: 20210517; Test Name: Mono %; Test Result: 4.6 %; Test Date: 20210520; Test Name: Mono %; Test Result: 3.6 %; Test Date: 20210524; Test Name: Mono %; Test Result: 7.5 %; Test Date: 20210527; Test Name: Mono %; Test Result: 4.5 %; Test Date: 20210531; Test Name: Mono %; Test Result: 3.7 %; Test Date: 20210507; Test Name: Neut #; Result Unstructured Data: Test Result:6.57 H; Test Date: 20210511; Test Name: Neut #; Result Unstructured Data: Test Result:5.59 H; Test Date: 20210514; Test Name: Neut #; Result Unstructured Data: Test Result:6.44 H; Test Date: 20210517; Test Name: Neut #; Result Unstructured Data: Test Result:10.64 H; Test Date: 20210520; Test Name: Neut #; Result Unstructured Data: Test Result:21.99 H; Test Date: 20210524; Test Name: Neut #; Result Unstructured Data: Test Result:10.87 H; Test Date: 20210527; Test Name: Neut #; Result Unstructured Data: Test Result:11.20 H; Test Date: 20210531; Test Name: Neut #; Result Unstructured Data: Test Result:22.94 H; Test Date: 20210507; Test Name: Neut %; Result Unstructured Data: Test Result:73.9 H %; Test Date: 20210511; Test Name: Neut %; Test Result: 69.4 %; Test Date: 20210514; Test Name: Neut %; Test Result: 69.7 %; Test Date: 20210517; Test Name: Neut %; Result Unstructured Data: Test Result:80.8 H %; Test Date: 20210520; Test Name: Neut %; Result Unstructured Data: Test Result:90.3 H %; Test Date: 20210524; Test Name: Neut %; Result Unstructured Data: Test Result:81.3 H %; Test Date: 20210527; Test Name: Neut %; Result Unstructured Data: Test Result:84.2 H %; Test Date: 20210531; Test Name: Neut %; Result Unstructured Data: Test Result:92.5 H %; Test Date: 20210507; Test Name: Seg; Result Unstructured Data: Test Result:74 H; Test Date: 20210514; Test Name: Seg; Result Unstructured Data: Test Result:65 H; Test Date: 20210517; Test Name: Seg; Result Unstructured Data: Test Result:80 H; Test Date: 20210520; Test Name: Seg; Result Unstructured Data: Test Result:89 H; Test Date: 20210531; Test Name: Seg; Result Unstructured Data: Test Result:91 H; Test Date: 20210507; Test Name: non HDL-C; Result Unstructured Data: Test Result:130; Test Date: 20210507; Test Name: PLT; Result Unstructured Data: Test Result:501 H; Test Date: 20210514; Test Name: PLT; Result Unstructured Data: Test Result:465 H; Test Date: 20210517; Test Name: PLT; Result Unstructured Data: Test Result:556; Test Date: 20210520; Test Name: PLT; Result Unstructured Data: Test Result:717 H; Test Date: 20210524; Test Name: PLT; Result Unstructured Data: Test Result:392; Test Date: 20210527; Test Name: PLT; Result Unstructured Data: Test Result:221; Test Date: 20210531; Test Name: PLT; Result Unstructured Data: Test Result:183; Test Date: 20210507; Test Name: PSA; Result Unstructured Data: Test Result:0.0; Test Date: 20210507; Test Name: TP; Result Unstructured Data: Test Result:6.4 L; Test Date: 20210514; Test Name: TP; Result Unstructured Data: Test Result:6.0 L; Test Date: 20210520; Test Name: TP; Result Unstructured Data: Test Result:6.3 L; Test Date: 20210527; Test Name: TP; Result Unstructured Data: Test Result:5.3 L; Test Date: 20210507; Test Name: HYPO; Result Unstructured Data: Test Result:+; Test Date: 20210511; Test Name: HYPO; Result Unstructured Data: Test Result:+; Test Date: 20210514; Test Name: HYPO; Result Unstructured Data: Test Result:+; Test Date: 20210517; Test Name: HYPO; Result Unstructured Data: Test Result:+; Test Date: 20210520; Test Name: HYPO; Result Unstructured Data: Test Result:++; Test Date: 20210524; Test Name: HYPO; Result Unstructured Data: Test Result:+++; Test Date: 20210527; Test Name: HYPO; Result Unstructured Data: Test Result:+++; Test Date: 20210531; Test Name: HYPO; Result Unstructured Data: Test Result:+++; Test Date: 20210524; Test Name: MACRO; Result Unstructured Data: Test Result:+; Test Date: 20210527; Test Name: MACRO; Result Unstructured Data: Test Result:+; Test Date: 20210531; Test Name: MACRO; Result Unstructured Data: Test Result:+; Test Date: 20210507; Test Name: RBC; Result Unstructured Data: Test Result:4.19; Test Date: 20210514; Test Name: RBC; Result Unstructured Data: Test Result:3.65 L; Test Date: 20210517; Test Name: RBC; Result Unstructured Data: Test Result:3.77 L; Test Date: 20210520; Test Name: RBC; Result Unstructured Data: Test Result:4.44; Test Date: 20210524; Test Name: RBC; Result Unstructured Data: Test Result:4.28; Test Date: 20210527; Test Name: RBC; Result Unstructured Data: Test Result:4.53; Test Date: 20210531; Test Name: RBC; Result Unstructured Data: Test Result:5.40; Test Date: 20210507; Test Name: RDW; Result Unstructured Data: Test Result:14.0; Test Date: 20210514; Test Name: RDW; Result Unstructured Data: Test Result:14.2; Test Date: 20210517; Test Name: RDW; Result Unstructured Data: Test Result:14.2; Test Date: 20210520; Test Name: RDW; Result Unstructured Data: Test Result:14.5; Test Date: 20210524; Test Name: RDW; Result Unstructured Data: Test Result:5.2; Test Date: 20210527; Test Name: RDW; Result Unstructured Data: Test Result:15.6 H; Test Date: 20210531; Test Name: RDW; Result Unstructured Data: Test Result:16.2 H,; Test Date: 20210507; Test Name: RETIC; Result Unstructured Data: Test Result:0.76; Test Date: 20210517; Test Name: RETIC; Result Unstructured Data: Test Result:1.68; Test Date: 20210518; Test Name: CoV2PCR; Result Unstructured Data: Test Result:(-); Test Date: 20210518; Test Name: Urinary pneumococcus; Result Unstructured Data: Test Result:(-); Test Date: 20210507; Test Name: TBA; Result Unstructured Data: Test Result:unknown results; Comments: request at 13:39 results at 13:51; Test Date: 20210524; Test Name: TBA; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:55 results at 09:06; Test Date: 20210527; Test Name: TBA; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:50 results at 09:01; Test Date: 20210531; Test Name: TBA; Result Unstructured Data: Test Result:unknown results; Comments: request at 08:42 results at 08:53; Test Date: 20210518; Test Name: Urinary sediment; Result Unstructured Data: Test Result:white blood cell (reference range: blank) less; Comments: than 1/HPF, squamous cell (reference range: blank) less than 1/HPF, transitional cell carcinoma (reference range: blank) 1-4/HPF, CoV2PCR (reference range: blank) (-), urinary pneumococcus (reference range: blank) (-), urinary legionella (reference range: blank) (-).; Test Date: 20210518; Test Name: General urinalysis; Result Unstructured Data: Test Result:urine color (reference range: blank) yellowish; Comments: brown, specific gravity (reference range: 1.002-1.03) 1.020, pH (reference range: 5.0-7.5) 5.5, protein (reference range: (-)) (+/-), sugar (reference range: (-)) (-), ketone body (reference range: (-)) (+/-), occult blood (reference range: (-)) (-), urobilinogen (reference range: 0.1-1.0) 0.1, white blood cell (reference range: (-)) (-), red blood cell (reference range: blank) less than 1/HPF.; Test Date: 20210507; Test Name: LEFT SHIFT; Result Unstructured Data: Test Result:+; Test Date: 20210511; Test Name: LEFT SHIFT; Result Unstructured Data: Test Result:+; Test Date: 20210514; Test Name: LEFT SHIFT; Result Unstructured Data: Test Result:+; Test Date: 20210520; Test Name: LEFT SHIFT; Result Unstructured Data: Test Result:+; Test Date: 20210507; Test Name: WBC; Result Unstructured Data: Test Result:8.90 H; Test Date: 20210514; Test Name: WBC; Result Unstructured Data: Test Result:9.25 H; Test Date: 20210517; Test Name: WBC; Result Unstructured Data: Test Result:13.16 H; Test Date: 20210520; Test Name: WBC; Result Unstructured Data: Test Result:24.36 H; Test Date: 20210524; Test Name: WBC; Result Unstructured Data: Test Result:13.36 H; Test Date: 20210527; Test Name: WBC; Result Unstructured Data: Test Result:13.31 H; Test Date: 20210531; Test Name: WBC; Result Unstructured Data: Test Result:24.79 H
CDC Split Type: JPPFIZER INC2021684924

Write-up: Cerebral infarction; Pneumonia; Consciousness disturbed; Ocular deviation; Taste disorder; Exertional shortness of breath; Aggravated knee pain; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21113014. A 93-year-old male received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET3674, Expiration date 31Jul2021) intramuscularly on 28Apr2021 at 15:09 at the age of 93-year-old as a single dose for COVID-19 immunisation. Body temperature before vaccination was 36.6 degrees centigrade. Family history was not reported. Medical history included bronchitis chronic, prostatic hyperplasia, varicose veins of lower extremities, old cerebral infarction, hyperuricaemia, and reflux oesophagitis. Concomitant medications included rebamipide, rabeprazole sodium (PARIET), ticlopidine hydrochloride (PANALDINE), levocetirizine dihydrochloride (XYZAL), dutasteride (AVOLVE), amlodipine besilate, azilsartan (ZACRAS), glycyrrhiza spp. root, paeonia lactiflora root (SHAKUYAKUKANZOTO), sennoside A+B, fexofenadine, celecoxib (CELECOX), tamsulosin hydrochloride (HARNAL), and paracetamol (CALONAL). On 28Apr2021 (the day of vaccination), the patient experienced taste disorder, exertional shortness of breath, and aggravated knee pain; the outcome of these events was unknown. On 07May2021 at 14:47 (9 days after the vaccination), the patient experienced pneumonia and cerebral infarction. On 31May2021 around 06:00 (33 days after the vaccination), the patient experienced consciousness disturbed and ocular deviation; the outcome of these events was unknown. On 02Jun2021 (35 days after the vaccination), the outcome of the events pneumonia and cerebral infarction was fatal. It was unknown whether autopsy was done. The patient was discharged on 02Jun2021. The course of the events was as follows: On 28Apr2021 (the day of vaccination), the patient received BNT162b2 intramuscularly. Thereafter, the patient started to experience taste disorder, exertional shortness of breath, aggravated knee pain, and other symptoms. On 07May2021 (9 days after the vaccination), on a regular check-up at the reporting hospital, severe pneumonia over the entire left lung was diagnosed based on various examinations, and the patient was admitted to the reporting department. The patient was treated with antimicrobial drugs for pneumonia but was poorly responsive to the treatment; pneumonia was aggravated, became bilateral, and turned to a serious condition. Thereafter, the antimicrobial drugs were changed twice, but pneumonia worsened. Concomitant use of steroid drugs and sedative drugs was started to alleviate the symptoms, after which pneumonia was slightly getting better. However, on 31May2021 around 06:00 (33 days after the vaccination), symptoms such as consciousness disturbed and ocular deviation developed, and the patient''s condition was suddenly aggravated. On the same day in the afternoon, computerised tomography (CT) test from the head through the trunk was performed but revealed no apparent abnormal findings in the head. However, based on the clinical symptoms and clinical course, cerebral infarction was strongly suspected. The condition was worsening afterwards, and on 02Jun2021 at 09:28 (35 days after the vaccination), the patient died. Regarding the suspected cerebral infarction, the patient had been possibly prone to develop cerebral infarction under the factors including severe pneumonia, dehydration due to pyrexia, and steroid use. However, the causal relationship could not be denied as there had been several reports on cerebrovascular disorder in death cases due to BNT162b2. Laboratory test: 07May2021: TP (reference value: 6.7-8.3) 6.4 low (L), ALB reference value: 4.0-5.0) 2.3 L, A/G (reference range: 1.3-2.2) 0.56 L, T-BIL (reference range: 0.3-1.2) 0.56, D-BIL (reference range: 0.0-0.3) 0.14, AST (GOT) (reference range: 13-33) 11 L, ALT (GPT) (reference range: 8-42) 8, LAP (reference range: 30-70) 36, G-GT (reference range: 16-73) 17, CHE (reference range: 185-431) 140 L, CPK (reference range: 62-287) 28 L, AMY (reference range: 42-158) 49, T-CHO (reference range: 128-219) 162, TG (reference range: 30-149) 97, HDL-C (reference range: 40 or above) 32 L, LDL-C (reference range: 70-139) 107, BUN (reference range: 8-22) 16.9, CRE (reference range: 0.6-1.1) 0.68, UA (reference range: 3.6-7.0) 4.6, Na (reference range: 138-146) 139, K (reference range: 3.6-4.9) 3.7, CI (reference range: 99-109) 102, CRP (reference range: 0-02) 18.24 high (H), GLU (reference range: 70-109) 223 H, eGFR (reference range: 90 or above) 80.6 L, LDL/HDL ratio (reference range: 0-2) 3.3 H, non HDL-C (reference range: blank) 130, LDH (IFCC) (reference range: 119-229) 160, ALP (IFCC) (reference range: 38-113) 122 H, blood sugar (reference range: 70-109) 223 H, CBC comment #1 (reference range: blank) large platelets, WBC (reference range: 4-9) 8.90 H, RBC (reference range: 4.1-5.5) 4.19, Hgb (reference range: 13-18) 12.0 L, HCT (reference range: 40-50) 38.1 L, MCV (reference range: 80-105) 90.8, MCH (reference range: 28-35) 28.6, MCHC (reference range: 32-36) 31.5 L, RDW (reference range: 11.0-15.5) 14.0, PLT (reference range: 130-400) 501 H, RETIC (reference range: 0.7-2.8) 0.76, Neut % (reference range: 37-73) 73.9 H, Lymp % (reference range: 20-55) 9.8 L, Mono % (reference range: 2-12) 3.5, Eos % (reference range: 0-7) 11.7 H, Baso % (reference range: 0-3) 0.4, LUC % (reference range: 0-4.5) 0.8, Neut # (reference range: 1.4-6.5) 6.57 H, Lymp # (reference range: 1.2-3.4) 0.87 L, Mono # (reference range: 0-1) 0.31, Eos # (reference range: 0-0.7) 1.04 H, Baso # (reference range: 0-0.2) 0.04, LUC # (reference range: 0-0.4) 0.07, LEFT SHIFT (reference range: blank) +, HYPO (reference range: blank) +, Meta (reference range: blank) 1, Seg (reference range: 45-55) 74 H, Eos (reference range: 1-6) 12 H, Mono (reference range: 2-8) 2, Lymp (reference range: 25-45) 11 L, CEA (reference range: 0.0-5.0) 5.6 H, CA19-9 (reference range: 0.0-37.0) lower than 2.00, PSA (reference range: 0.0-4.0) 0.0, HBs-Ag (reference range: 0.00-0.04) 0.00, HBsAg quantitative (-), HVC-Ab (reference range: 0.00-1.00) 0.08, HCVAb quantitative (reference range: blank) (-), electrocardiogram (reference range: blank) completed, BNP (reference range: 0.0-18.4) 42.9 H, TBA request at 13:39 (reference range: blank), TBA results at 13:51 (reference range: blank), Advia request at 13:30 (reference range: blank), Advia results at 13:31 (reference range: blank), ARCHITECT request at 13:35 and 14:56 (reference range: blank), ARCHITECT results at 13:51 and 15:55 (reference range: blank), GA08 results at 13:32 (reference range: blank). 11May2021: BUN 7.6 L, CRE 0.66, Na 136 L, K 4.0, CI 102, CRP 13.28 H, eGFR 83.2 L, Neut % 69.4, Lymp % 9.3 L, Mono % 6.8, Eos % 12.5 H, Baso % 0.7, LUC % 1.2, Neut # 5.59 H, Lymp # 0.75 L, Mono # 0.55, Eos # 1.01 H, Baso # 0.06, LUC # 0.10 LEFT SHIFT +, HYPO +. 14May2021: TP 6.0 L, ALB 2.0 L, A/G 0.50 L, T-BIL 0.42, AST (GOT) 13, ALT (GPT) 11, G-GT 16, CPK 21 L, BUN 11.2, CRE 0.68, Na 136 L, K 4.2, CI 102, CRP 19.15 H, eGFR 80.6 L, LDH (IFCC) 165, ALP (IFCC) 95, CBC comment #1 large platelets, CBC comment #2 PLT granulocyte anisocytosis, WBC 9.25 H, RBC 3.65 L, Hgb 10.3 L, HCT 32.6, MCV 89.6, MCH 28.3, MCHC 31.7 L, RDW 14.2, PLT 465 H, Neut % 69.7, Lymp % 8.1 L, Mono % 6.9, Eos % 14.3 H, Baso % 0.4, LUC % 0.7, Neut # 6.44 H, Lymp # 0.75 L, Mono # 0.64, Eos # 1.32 H, Baso # 0.04, LUC # 0.06, LEFT SHIFT +, HYPO +, Seg 65 H, Eos 20 H, Mono 7, Lymp 8 L. 17May2021: BUN 12.3, CRE 0.84, Na 137 L, K 4.3, CI 103, CRP 22.85 H, eGFR 63.9 L, WBC 13.16 H, RBC 3.77 L, Hgb 10.8 L, HCT 33.7 L, MCV 89.3, MCH 28.7, MCHC 32.2, RDW 14.2, PLT 556 H, RETIC 1.68, Neut % 80.8 H, Lymp % 6.9 L, Mono % 4.6, Eos % 6.5, Baso % 0.4, LUC % 0.7, Neut # 10.64 H, Lymp # 0.91 L, Mono # 0.61, Eos # 0.86 H, Baso # 0.06, LUC # 0.09, HYPO +, Seg 80 H, Eos 5, Mono 8, Lymp 7 L. 18May2021: General urinalysis: urine color (reference range: blank) yellowish brown, specific gravity (reference range: 1.002-1.03) 1.020, pH (reference range: 5.0-7.5) 5.5, protein (reference range: (-)) (+/-), sugar (reference range: (-)) (-), ketone body (reference range: (-)) (+/-), occult blood (reference range: (-)) (-), urobilinogen (reference range: 0.1-1.0) 0.1, white blood cell (reference range: (-)) (-), red blood cell (reference range: blank) less than 1/HPF. Urinary sediment: white blood cell (reference range: blank) less than 1/HPF, squamous cell (reference range: blank) less than 1/HPF, transitional cell carcinoma (reference range: blank) 1-4/HPF, CoV2PCR (reference range: blank) (-), urinary pneumococcus (reference range: blank) (-), urinary legionella (reference range: blank) (-). 20May2021: TP 6.3 L, ALB 2.0 L, A/G 0.47 L, T-BIL 0.36, AST (GOT) 53 H, ALT (GPT) 24, G-GT 22, CPK 83, BUN 25.5 H, CRE 0.95, Na 138, K 4.6, CI 101, CRP 13.62 H, eGFR 55.9 L, LDH (IFCC) 251 H, ALP (IFCC) 94, WBC 24.36 H, RBC 4.44, Hgb 12.4 L, HCT 40.1, MCV 90.4, MCH 28.0, MCHC 30.9 L, RDW 14.5, PLT 717 H, Neut % 90.3 H, Lymp % 5.0 L, Mono % 3.6, Eos % 0.4, Baso % 0.2, LUC % 0.4, Neut # 21.99 H, Lymp # 1.22, Mono # 0.89, Eos # 0.10, Baso # 0.05, LUC # 0.11, LEFT SHIFT +, HYPO ++, Meta 1, Seg 89 H, Mono 4, Lymp 6 L, electrocardiogram completed. 24May2021: BUN 36.4 H, CRE 0.72, Na 139, K 4.6, CI 97 L, CRP 2.70 H, eGFR 71.3 L, WBC 13.36 H, RBC 4.28, Hgb 11.9 L, HCT 40.6, MCV 94.8, MCH 27.8 L, MCHC 29.4 L, RDW 15.2, PLT 392, Neut % 81.3 H, Lymp % 9.5 L, Mono % 7.5, Eos % 0.2, Baso % 0.3, LUC % 1.2, Neut # 10.87 H, Lymp # 1.27, Mono # 1.00, Eos # 0.03, Baso # 0.04, LUC # 0.16, MACRO (reference range: blank) +, HYPO +++, TBA request at 08:55, TBA results at 09:06, Advia request at 08:33, Advia results at 08:34. 27May2021: TP 5.3 L, ALB 2.3 L, A/G 0.77 L, T-BIL 0.35, AST (GOT) 15, ALT (GPT) 11, G-GT 24, CPK 26 L, BUN 32.1 H, CRE 0.59 L, Na 153 H, K 5.3 H, CI 105, CRP 1.28 H, eGFR 94.1, LDH (IFCC) 148, ALP (IFCC) 60, WBC 13.31 H, RBC 4.53, Hgb 12.6 L, HCT 43.0, MCV 95.0, MCH 27.7 L, MCHC 29.2 L, RDW 15.6 H, PLT 221, Neut % 84.2 H, Lymp % 10.3 L, Mono % 4.5, Eos % 0.2, Baso % 0.1, LUC % 0.7, Neut # 11.20 H, Lymp # 1.37, Mono # 0.60, Eos # 0.03, Baso # 0.01, LUC # 0.09, MACRO +, HYPO +++, TBA request at 08:50, TBA results at 09:01, Advia request at 08:40, Advia results at 08:42, KL-6 (reference range: less than 500) 272. 31May2021: BUN 27.4 H, CRE 0.76, Na 150 H, K 6.2 H, CI 108, CRP 1.44 H, eGFR 75.7 L, CBC comment #1 large platelets, WBC 24.79 H, RBC 5.40, Hgb 15.2, HCT 50.7 L, MCV 93.9, MCH 28.1, MCHC 29.9 L, RDW 16.2 H, PLT 183, Neut % 92.5 H, Lymp % 3.0 L, Mono % 3.7, Eos % 0.1, Baso % 0.2, LUC % 0.5, Neut # 22.94 H, Lymp # 0.74 L, Mono # 0.93, Eos # 0.02 H, Baso # 0.04, LUC # 0.12, LPLT +, ANISO +, MACRO +, HYPO +++, Stab (reference range: 2-13) 2, Seg 91 H, Eos 1, Mono 4, Lymp 2 L, electrocardiogram completed, TBA request at 08:42, TBA results at 08:53, Advia request at 08:44, Advia results at 08:45, Rapid results (reference range: blank) 08:31, Blood gases at 06:21:06: ABG pH (reference range: 7.4-7.5): 7.210 L, ABG PC02 (reference range: 35-45) 71.3 H, ABG P02 (reference range: 75-100) 66.4 L, ABG HC03-s (reference range: 23-28) 22.7 L, ABG HC03-a (reference range: 23-28) 27.9, ABG BE (vt) (reference range: -3-3) -1.9, ABG BE (vv) (reference range: blank) 0.0, ABG tC02 (reference range: 22-30) 30.1 H, ABG Na (reference range: 138-146) 136.2 L, ABG K (reference range: 3.6-4.9) 4.85, ABG CI (reference range: 99-109) 99, ABGAnGap+K (reference range: 10-18) 14.2, ABGAnGap-K (reference range: 7-14) 14.2 H, ABG Ca++ (reference range: 1.1-1.3) 1.17, ABG Ca++ corrected (reference range: blank) 1.08, ABG GLU (reference range: 70-109) 148 H, ABG S02 (reference range: blank) 88.9, ABG tHb (reference range: blank) 14.6, ABG 02Hb (reference range: blank) 86.9, ABG C0Hb (reference range: blank) 2.0, ABG MetHb (reference range: blank) 0.3, ABG HHb (reference range: blank) 10.8. The reporting physician classified the events pneumonia and cerebral infarction as serious (hospitalization) and assessed the causality between the event pneumonia and cerebral infarction and BNT162b2 as unassessable. Other possible cause of the events pneumonia and cerebral infarction such as any other diseases: present (the possibility of typical refractory bacterial pneumonia was undeniable). The seriousness and causality of the other events were not reported. The reporting physician commented as follows: Despite the lack of underlying disease in the lung and the low risk for drug-resistant bacteria, pneumonia was refractory, and although 3 antimicrobial drugs were used in total, the treatment was poorly effective and resulted in gradual aggravation. Considering that pneumonia was too refractory for typical bacterial pneumonia and was seemingly resolving since the use of steroids for alleviation, the possibility of drug-induced pneumonia could not be completely denied.; Reported Cause(s) of Death: Cerebral infarction; Pneumonia


VAERS ID: 1428937 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7388 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARIPIPRAZOLE; MADOPAR; MINITRO; ZOLPIDEM
Current Illness: Hospitalisation
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic kidney disease
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021685560

Write-up: Acute on chronic heart failure; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution and follow-up report from the same contactable physician ("inocubator") received from the Agency Regulatory Authority. Regulatory authority report number is v21113386. A 96-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 09Jun2021 14:11 (Batch/Lot Number: FA7388; Expiration Date: 30Sep2021) as SINGLE DOSE for COVID-19 immunisation. Medical history included cardiac failure chronic from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing, ongoing hospitalisation from an unknown date. Concomitant medications included aripiprazole (MANUFACTURER UNKNOWN); benserazide hydrochloride, levodopa (MADOPAR); glyceryl trinitrate (MINITRO); zolpidem (MANUFACTURER UNKNOWN); all taken for an unspecified indication, start and stop date were not reported. On 09Jun2021 at 23:20, the patient experienced: acute on chronic heart failure (death, hospitalization, medically significant, life threatening). The patient''s hospitalization was prolonged as a result of acute on chronic heart failure. The clinical course was reported as follows: The patient was a 96-year and 5-month-old male. On 19May2021, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received oral aripiprazole and oral benserazide hydrochloride, levodopa (MADOPAR), oral zolpidem, and glyceryl trinitrate (MINITRO, tape) 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 cardiac failure chronic and chronic kidney disease. The patient had no family history. Body temperature before vaccination was 36.5 degrees Centigrade. On 09Jun2021 at 14:11 (also reported as 11:15) (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7388, Expiration date 30Sep2021) intramuscularly for COVID-19 immunization. On 09Jun2021 at 23:20 (9 hours 9 minutes after the vaccination), the patient experienced acute on chronic heart failure. The event resulted in death, life-threatening (the risk of death due to adverse event, prolongation of hospitalization (the patient received vaccination during hospitalisation)) The outcome of the event was fatal with treatment including oxygen administration, intravenous (IV) fluid, and diuretics. Since the vaccination, the patient has not been tested for COVID-19. Clinical course was reported as follows: After vaccination, no significant changes were noted. Around 9 hours after vaccination, oxygenation decreased. No rash or remarkable blood pressure decreased was observed. The patient was being observed with oxygen administration, IV fluid, and diuretics. However, oxygenation decreased progressed, and the patient died on 11Jun2021 at 06:23 (also reported as 06:00). No pyrexia was noted during the course. Cause of death was reported as acute on chronic heart failure. The reporting physician classified the event as serious (death) and that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac failure chronic and chronic kidney disease. The patient underwent lab tests and procedures which included body temperature: 36.5 Centigrade on 09Jun2021 (before vaccination). Therapeutic measures were taken as a result of acute on chronic heart failure. The clinical outcome of the event, acute on chronic heart failure, was fatal. The patient died on 11Jun2021 due to acute on chronic heart failure. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Acute on chronic heart failure


VAERS ID: 1428938 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, Cerebral infarction, Magnetic resonance imaging head, Respiratory disorder
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (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: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Intestinal obstruction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: Head MRI; Result Unstructured Data: Test Result:Diagnosis of cerebral infarction; Comments: Diagnosis of acute stage cerebral infarction in the right hemisphere was made
CDC Split Type: JPPFIZER INC2021685577

Write-up: atrial fibrillation; Acute stage cerebral infarction in the right hemisphere; Respiratory status declined; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21113049. An 88-year and 11-month-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EY4834, expiration date: 31Aug2021), at the age of 88 years old, on 28May2021 at 15:00 at single dose for covid-19 immunisation. Medical history included ongoing intestinal obstruction. The patient had no family history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees centigrade. On 28May2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 04Jun2021 at 07:45 (6 days 16 hours 45 minutes after the vaccination), the patient experienced acute stage cerebral infarction in the right hemisphere. On 04Jun2021 (7 days after the vaccination), the outcome of the event was fatal. The clinical course was reported as: The patient had been hospitalized due to intestinal obstruction. On 04Jun2021 at 07:45, consciousness disturbed, left hemiplegia, and conjugate deviation suddenly developed. Diagnosis of acute stage cerebral infarction in the right hemisphere was made based on head magnetic resonance imaging (MRI). Administration of alteplase (tPA, GRTPA injection) was initiated, however, condition of the patient aggravated in a short time. Respiratory status declined and on the same day at 13:35, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was atrial fibrillation. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: atrial fibrillation; Acute stage cerebral infarction in the right hemisphere; Respiratory status declined


VAERS ID: 1428940 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-10
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-26
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: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021685604

Write-up: This is a spontaneous report from a contactable physician. The patient was a 79-year-old male. Medical history included dialysis. On 26May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, solution for injection) via an unspecified route of administration at single dose for COVID-19 immunization. On 10Jun2021 (15 days after the vaccination), the patient experienced death. On 10Jun2021 in the morning (15 days after the vaccination), the outcome of event was fatal. The course of the event was as follows: The patient was on dialysis. On 26May2021, the patient received COMIRNATY. On 10Jun2021, the condition of the patient took a sudden turn for the worse and was transferred to a hospital; however, the patient died in the morning of 10Jun2021. It was unknown if an autopsy was performed or not. Since cause of death was unknown, causality was also unknown. Seriousness criteria was not provided. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. The information on the lot/batch number has been requested.; Sender''s Comments: The event death is assessed as related to COMIRNATY use and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1428947 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (under hospital treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:unmeasurable state; Test Date: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210602; Test Name: SpO2; Result Unstructured Data: Test Result:unmeasurable state
CDC Split Type: JPPFIZER INC2021686832

Write-up: cardio-respiratory arrest; Loss of consciousness; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21113268. The patient was an 81-year and 1-month-old female. Body temperature before vaccination was 36.7 degrees centigrade. Medical history included dementia (under hospital treatment). The patient was being hospitalized for the treatment of dementia. No information on concomitant medications or family history was provided. On 26May2021 at 14:32 (the day of vaccination, at age of 81 years old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 at around 15:00 (7 days after the vaccination), the patient experienced loss of consciousness. On 02Jun2021 at around 15:30 (7 days after the vaccination), the patient experienced cardio-respiratory arrest. The course of the events was as follows: On 02Jun2021 at around 15:00, she suddenly lost consciousness. Blood pressure and SpO2 (oxygen saturation percutaneous) could not be measured. Her consciousness did not recover. Therefore, an emergency service was requested. At 15:30, cardio-respiratory arrest developed. Resuscitation was attempted. At another hospital where she was transferred, she was resurrected once but on the same day, she passed away. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. It was uncertain if there was possible cause of the events such as any other diseases.; Reported Cause(s) of Death: cardio-respiratory arrest; Loss of consciousness


VAERS ID: 1428948 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: Emphysema; Hypertension; Interstitial pneumonia; Myocardial infarction; Physical deconditioning; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210609; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:the electrocardiographic waveform still showed asy
CDC Split Type: JPPFIZER INC2021687103

Write-up: Cardio-respiratory arrest; he had suddenly loss of consciousness and fell in front of his wife; he had suddenly loss of consciousness and fell in front of his wife; Heat illness; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21113108 and a second contactable physician received from the same regulatory authority. Regulatory authority report number is v21113548. The first physician reported that the patient was a 78-year-old male. Body temperature before vaccination was not provided. The patient lived with his wife (hearsay). On 09Jun2021 at around 11:00 (the day of vaccination, at age of 78 years old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jun2021 at 11:00 (the day of the vaccination), the patient experienced death. On 09Jun2021 (the day of the vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable (since the investigation was being performed, the details were unknown as of this date). It was not provided whether there was no other possible cause of the event such as any other diseases or not. The reporting physician commented as follows: In this case, an autopsy was performed based on the law regarding the cause of death or a background check which were deal with the police. The second physician reported that the patient was a 78-year-old male. The time of the vaccination updated as 11:30, the time of onset of the event (12:00), the body temperature before vaccination (36.6 degrees Celsius), the medical histories (interstitial pneumonia, emphysema, and hypertension). The course of the event was as follows: On 09Jun2021 (the time of vaccination), at 11:45 (15 minutes after vaccination), no symptoms such as anaphylaxis were observed, and the patient went home by a taxi at around 12:00 (30 minutes after vaccination). The patient got off the taxi near his home, and while he was slowly walking in the hot sun, he had loss of consciousness and cardio-respiratory arrest. The outcome of event Cardio-respiratory arrest was fatal, event Loss of consciousness was not recovered, unknown for rest events. The reporting physician (second physician) assessed the causality between the events and BNT162b2 was unassessable. Heat illness was reported as other possible cause of the event such as any other diseases or not. The treatment information included: Disease Name: Cardio-respiratory arrest at the hospital visit (CPAOA). The patient had no history of screening in the reporting hospital, and the assumption of the cause of death was difficult. Thus, an autopsy was asked to the police as abnormal death. The medical history and family history: All of the following information was heard from his wife. Myocardial infarction: Approximately 2 years ago, the patient had history of hospitalization and treatment (the details of the treatment were not heard) in another hospital. As of this date, the patient was visiting the hospital regularly. In May2021, when it was the final hospital visit, the patient was told that no particular changes were observed. Interstitial pneumonia: Home oxygen therapy was prescribed, and oxygen inhalation was performed at the time of cardio-respiratory arrest. The clinical course: On 09Jun2021 (the day of vaccination), after the patient received the first dose of BNT162b2 individual vaccination in the reporting hospital, he got in a taxi to go home and got off near his home. However, while the patient was slowly walking in the hot sun, he had suddenly loss of consciousness and fell in front of his wife. Immediately, an ambulance was called, and at 11:39 (9 minutes after vaccination), the fire department got the call, and at 11:46 (16 minutes after vaccination), the emergency service worker contacted with the patient. However, the patient had already been in cardio-respiratory arrest (the initial electrocardiographic waveform showed asystole). When the patient was transferred to the reporting hospital, the electrocardiographic waveform still showed asystole, and the pupil already dilated. Although cardiopulmonary resuscitation, which was continued from the site, was continued, no response was obtained at all. Thus, at 12:50 (one hour and 20 minutes after vaccination), the patient was confirmed to die with the presence of his wife. At the time of confirmation of the death, the recent living conditions of the patient was confirmed as follows: Around in Apr2021, the patient had severe shortness of breath on exertion, and he could walk for approximately one hour with frequent stops on the way on which the healthy individual could walk for only 10 minutes. In May2021, at the time of periodical hospital visit to his local hospital, the patient could not get out because of shortness of breath on exertion, and only his wife was examined, and she got regular prescription drugs. At that time, the wife asked the physician whether the patient should receive BNT162b2 vaccination or not, and she was explained that the patient should receive it. Several days ago, the patient was tired after he went to the restroom at home. Thus, the patient asked his wife to buy some kinds of container on which the patient could pass urine without going to the restroom. Although the wife understood the patient''s recent physical deconditioning, she was worried whether the patient really should receive BNT162b2 vaccination or not. However, the patient himself wished to receive the vaccination, and his wife respected his sentiment. It was not deniable that the patient whose physical condition was significantly poor received the vaccination. However, it could not help but be said that the causality between the cardio-respiratory arrest this time and BNT162b2 vaccination was unknown. Thus, this case was reported as abnormal death to the police concerned in the site of onset of cardio-respiratory arrest, and an autopsy was to be performed. Thus, the dead body of the patient was collected by the police.; Reported Cause(s) of Death: Cardio-respiratory arrest; death


VAERS ID: 1428950 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Cerebrovascular accident
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), Cardiomyopathy (broad), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccinaiton
CDC Split Type: JPPFIZER INC2021687159

Write-up: Cardiac arrest; the patient was suspected to have stroke; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21113109. The patient was an 87-year and 2-month-old male. Body temperature before vaccination was 36.6 degrees Centigrade. The family history was unknown. 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 27May2021 (the day of vaccination, at age of 87 years old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29May2021 at 09:00 (2 days after the vaccination), the patient experienced cardiac arrest. On 29May2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27May2021 (the day of vaccination), no abnormalities were observed in the health condition. On the day of vaccination, in the morning, the patient had a checkup. While the patient was taking meal, he became quiet, fell like in his sleep, and had cardiac arrest. The patient was transferred to the hospital by an ambulance. Imaging findings showed no abnormalities on the brain and the chest. 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: When this case was initially reported, the patient was suspected to have stroke.; 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: stroke; cardiac arrest


VAERS ID: 1428953 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: MEMANTINE HYDROCHLORIDE; SODIUM VALPROATE; POTASSIUM GLUCONATE; LANSOPRAZOLE; AMLODIPINE; DOXAZOSIN; DAIKENCHUTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Catheter infection; COVID-19; Dementia; Dysphagia; Femur fracture; Novel COVID-19-infected pneumonia; Pneumonia aspiration; Pneumonia bacterial
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:37.9/ 37.0 Centigrade; Comments: after vaccination noon/ evening
CDC Split Type: JPPFIZER INC2021687659

Write-up: Acute respiratory failure; fever of 37.9 centigrade; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. Regulatory authority report number is v21113566. A 78-year-old non-pregnant female patient received?the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) intramuscular in left arm on 09Jun2021 at 16:35(the day of vaccination) at single dose at the age of 78 years old for covid-19 immunisation. Body temperature before vaccination was 36.1 degrees Centigrade on 09Jun2021.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Allergic information was not provided. Since the vaccination, the patient has not been tested for COVID-19. Medical history included pneumonia bacterial, catheter infection, femur fracture from Dec2020, dementia, dysphagia, pneumonia aspiration, COVID-19 from 15Apr2021, Novel COVID-19-infected pneumonia. Family history was not provided. The patient previously took antibiotic treatment included TAZOPIPE from 02May2021 to 21May2021 and Arbekacin Sulfate from 05May2021 to 21May2021. Concomitant medications included memantine hydrochloride ; sodium valproate; potassium gluconate; lansoprazole; amlodipine; doxazosin; and panax ginseng root, zanthoxylum piperitum pericarp, zingiber officinale processed rhizome (DAIKENCHUTO). On 11Jun2021 at 01:10 (2 days after the vaccination), the patient experienced acute respiratory failure. No treatment was received for the event acute respiratory failure. Death cause was reported as acute respiratory failure. The patient died on 11Jun2021. An autopsy was not performed. The course of the event was as follows: The patient was admitted nursing care facility for dementia. In Dec2020, the patient was hospitalized at previous hospital for femur fracture where pneumonia aspiration also developed and additional treatment was given. In Jan2021, the patient was transferred to the reporting hospital. Although oral ingestion was continued, the patient repeatedly developed pneumonia. On 15Apr2021, the patient was infected with COVID-19 in the hospital and developed pneumonia. Pneumonia bacterial and catheter infection developed but were resolving. After 21May2021, antibiotic treatment was not needed, and her condition was stable. In the evening on 09Jun2021, the patient received BNT162b2. On 10Jun2021, fever of 37.9 centigrade was noted. In the evening on the same day, fever decreased spontaneously to 37.0 centigrade and no specific problem was noted. However, on 11Jun2021 at 1:00, the patient was found as respiratory arrest. The patient had policy of do not attempt resuscitate (DNAR). At 2:14, her death was confirmed. The patient underwent lab test included body temperature: 36.1 Centigrade on 09Jun2021(before vaccination), 37.9/ 37.0 Centigrade on 10Jun2021(after vaccination noon/ evening). The outcome of the event Acute respiratory failure was fatal, of the event" fever of 37.9 centigrade" was recovered. The reporting physician classified the event as serious (fatal) and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was pulmonary embolism or myocardial infarction.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1428955 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, End stage renal disease
SMQs:, Rhabdomyolysis/myopathy (broad), Chronic kidney disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: FUROSEMIDE; TELMISARTAN; AMLODIPINE; FERROMIA; TAKELDA; FEXOFENADINE; NALFURAFINE; MASHININGAN; EQUA; CELESTAMINE [BETAMETHASONE;DEXCHLORPHENIRAMINE MALEATE]; GLYCYRON [DL-METHIONINE;GLYCINE;GLYCYRRHIZIC ACID, AMMONIUM SALT]; ATARAX-P [HYDR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Cerebral infarction; Dementia; Disuse syndrome; Haemodialysis; Heart disorder; Renal failure chronic; Thoracic aortic aneurysm; Type 2 diabetes mellitus; Vascular stent insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021687766

Write-up: End stage renal disease; This is a spontaneous report from a contactable pharmacist and physician received via COVID-19. Regulatory authority report number is v21113587. The patient was an 89-year and 10-month-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified prescription drug(s) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included type 2 diabetes mellitus not ongoing, cerebral infarction not ongoing, cerebral haemorrhage, renal failure chronic, haemodialysis(initiated in 2016), heart disorder, surgery for thoracic aortic aneurysm in Jan2021, disuse syndrome, and dementia. Concomitant medications included furosemide, tablet, strength: 40 mg; telmisartan, tablet, strength: 80 mg; amlodipine, tablet, strength: 10 mg; ferrous sodium citrate (FERROMIA) tablet, strength: 50 mg; acetylsalicylic acid, lansoprazole (TAKELDA) Combination Tablets; fexofenadine, tablet, strength: 60 mg; nalfurafine, tablet, strength: 2.5 ug, cannabis sativa fruit, citrus spp. unripe fruit, magnolia spp. bark, paeonia lactiflora root, prunus spp. seed, rheum spp. rhizome (MASHININGAN); vildagliptin (EQUA), tablet, strength: 50 mg; betamethasone, dexchlorpheniramine maleate (CELESTAMINE) Combination Tablets; dl-methionine, glycine, glycyrrhizic acid, ammonium salt (GLYCYRON) Tablets and hydroxyzine hydrochloride (ATARAX-P), strength: 25 mg, all taken orally for unspecified indications, start dates were not reported and ongoing. On 20May2021 at 11:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY2173, Expiration date 31Aug2021) intramuscularly at single dose at the age of 89 years old for COVID-19 immunisation and experienced dementia aggravated. On 10Jun2021 at 11:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) intramuscularly at single dose at the age of 89 years old for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade. On 11Jun2021 at 16:50 (1 day 5 hrs 50 min after the vaccination), the patient died due to end stage renal disease. An autopsy was not performed. The outcome of the event was fatal without treatment. The course of the event was as follows: The patient had medical history including type 2 diabetes mellitus and cerebral infarction. In 2016, haemodialysis was initiated for end stage renal failure. In January 2021, stent graft was inserted for thoracic aortic aneurysm. Subsequently, since 14Jan2021, the patient has been hospitalized in the reporting hospital and treated due to disuse syndrome. On 20May2021, the patient received the first dose of the vaccine and developed no particular problem. Since the beginning of June, dementia has aggravated. The patient rejected most of the meals and medications. On 10Jun2021, the patient received the second dose of the vaccine and developed no allergy. On 11Jun2021 at 16:50, the patient had respiratory arrest and death was confirmed. The patient underwent lab test included body temperature: 36.5 Centigrade on 10Jun2021(before vaccination). Since the vaccination, the patient has not been tested for COVID-19. The reporting pharmacist classified the event as serious (death). Causality was provided as unrelated. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was end stage renal failure.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of end stage renal disease. The reported event likely represent intercurrent medical condition in this elderly patient with history of type 2 diabetes mellitus and renal failure chronic on haemodialysis. 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: End stage renal disease


VAERS ID: 1428962 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalisation
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Fracture; Pleurisy; Postoperative infection; Wound irrigation (On 28Dec2020, and 09Mar2021, an incisional wound irrigation was performed.)
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021690879

Write-up: Respiratory arrest; This is a spontaneous report from a contactable consumer received via COVID-19 Adverse Event Self-Reporting Solution (COVAES), and a contactable physician received from the regulatory authority. Regulatory authority report number is v21113753. A 93-year-old and 1-month-old female patient (non-pregnant) received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 11Jun2021 14:00 (at the age of 93-year-old and 1-month-old) (Lot Number: FA4597; Expiration Date: 31Aug2021) as single dose for COVID-19 immunization. The patient had medical histories of diabetes mellitus, chronic pleurisy, and infection after postoperative left petrochanteric fracture on 17Dec2020, incisional wound irrigation was performed on 28Dec2020 and 09Mar2021. The detail of patient''s history before vaccination was provided as follows: The general conditions including diabetes mellitus (DM) were not stabilized, and the patient was being admitted to the hospital for treatment for a long time. However, recently, the symptoms improved, and the patient was preparing for discharge. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. Body temperature was 36.4 centigrade before vaccination on 11Jun2021. The time of onset of the event was on 12Jun2021 at 05:50. On 12Jun2021, at 05:50 (15 hours and 50 minutes after vaccination), the patient was found with respiratory arrest. No response to resuscitation was obtained. On 12Jun2021, at 06:28 (16 hours and 28 minutes after vaccination), the patient died. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was fatal. An autopsy was performed (detail was not provided). 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 as follows: The patient was an elderly, and she had medical history of chronic pleurisy.; Sender''s Comments: A causal association between the event and BNT162B2 cannot be excluded considering the temporal association. The underlying risk factors patient''s advanced age, diabetes mellitus and chronic pleurisy might have contributed to the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1428965 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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: Prostate cancer (for which the patient was under medical care)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021690909

Write-up: Cardio-respiratory arrest; pyrexia; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority report number is v21113303. An 87-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: FA4597; Expiration Date: 31Aug2021), via an unspecified route of administration on 08Jun2021 at 14:00 at a single dose for covid-19 immunisation; levofloxacin (MANUFACTURER UNKNOWN), via an unspecified route of administration on 10Jun2021 at 500 mg for an unspecified indication. Medical history included ongoing prostate cancer (for which the patient was under medical care). The patient''s concomitant medications were not reported. On 09Jun2021, the patient experienced pyrexia. On 10Jun2021 at 18:00, the patient experienced cardio-respiratory arrest, which was serious for death and required emergency room visit. On 08Jun2021 at around 14:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 10Jun2021 at around 18:00 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 10Jun2021 (2 days after the vaccination), the outcome of the event was fatal (death). The course of the event was as follows: on 08Jun2021, the patient received the vaccine. On the following day, the patient developed pyrexia. On 10Jun2021, levofloxacin 500 mg was prescribed. On the same day at around 18:00, the patient was found to have cardio-respiratory arrest and was taken to a hospital by ambulance and death was confirmed. The patient underwent lab tests and procedures which included body temperature: 36.9 degrees Centigrade on 08Jun2021 before vaccination. The action taken in response to the event for levofloxacin was not applicable. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the event, cardio-respiratory arrest, was fatal. The patient died on 10Jun2021 due to cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were advanced age and the patient was under medical care for prostate cancer. The reporting physician commented as follows: although causality was unknown, the case was reported because the patient died 2 days after the vaccination. Pfizer is a marketing authorization holder of levofloxacin. This may be a duplicate report if another marketing authorization holder of levofloxacin has submitted the same report to the regulatory authorities.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1428975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiogenic shock, Echocardiogram, Electrocardiogram, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: AVOLVE; ADOAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Drug allergy; Prostatitis; Sinusitis
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210610; Test Name: echocardiogram; Result Unstructured Data: Test Result:diffuse hypokinesia; Test Date: 20210610; Test Name: ECG; Result Unstructured Data: Test Result:slow VT
CDC Split Type: JPPFIZER INC2021691119

Write-up: Myocardial infarction; Cardiogenic shock; This is a spontaneous report from a contactable physician and pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21113588. The patient was an 81-year and 7-month-old male. Body temperature before vaccination was 36.7 degrees centigrade. The patient had medical histories of bronchial asthma, prostatitis, sinusitis, and aspirin allergy. Concomitant medications included dutasteride (AVOLVE) and salmeterol xinafoate fluticasone propionate (ADOAIR). On 04Jun2021 at 14:04 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at 23:00 (6 days, 8 hours, and 56 minutes after the vaccination), the patient experienced myocardial infarction and cardiogenic shock. On 11Jun2021 (7 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 10Jun2021 at around 23:00 (6 days, 8 hours, and 56 minutes after vaccination), chest pain and back pain appeared, and he was emergently transferred. ECG at the hospital visit showed slow VT, and the echocardiogram showed diffuse hypokinesia. The patient was suspected to have acute myocardial infarction (AMI) whose responsible lesion was the left main trunk (LMT). The patient was in a shock condition, and adrenaline was administered, and the patient was managed with intubation. An emergency coronary angiography (CAG) was performed, and an intra-aortic balloon pump (IABP) was inserted. Obstructions were observed in LMT (#5)100%; LAD (#6) 100%, LCX (#11)100%. Thus, an emergency percutaneous coronary intervention (PCI) was performed; however, shock and VT/VF storm did not improve, and the patient died at 02:58 on 11Jun2021 (6 days, 12 hours, and 54 minutes after vaccination). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Myocardial infarction; Cardiogenic shock


VAERS ID: 1428977 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Body temperature, Deep vein thrombosis, Dehydration, Visual acuity reduced
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: Cancer surgery; Gastric cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021691139

Write-up: Acute renal failure; DVT (deep vein thrombosis); dehydration; weakness generalized; Visual acuity reduced; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21113409. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 25Apr2021 (Batch/Lot Number: ER7449; Expiration Date: 30Jun2021) at 82-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included gastric cancer from an unknown date and unknown if ongoing, surgery for gastric cancer in 2015. Concomitant medications were not reported. On 27Apr2021, the patient experienced: visual acuity reduced (medically significant). On 09May2021, the patient experienced: weakness generalized (medically significant). On 11May2021, the patient experienced: deep vein thrombosis (DVT) (medically significant), and dehydration (medically significant). On 12May2021 12:40, the patient experienced: acute renal failure (death, medically significant) The clinical course was reported as follows: The patient was an 82-year and 1-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. Family history was not reported. Medical history included surgery for gastric cancer in 2015. On 25Apr2021 in the afternoon (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 12May2021 at 12:40 (17 days after the vaccination), the patient experienced acute renal failure. On 12May2021 (17 days 12 hours 40 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 25Apr2021, the patient received the vaccine. At around 27Apr2021, the patient developed visual acuity reduced; however, on 29Apr2021, it improved. On 09May2021, the patient developed weakness generalized. On 11May2021, the patient visited another hospital. The patient had swelling of the right leg and was diagnosed with DVT (deep vein thrombosis). The patient had dehydration. Balloon catheter collected 2 L of urine. On 12May2021 at 12:40, the patient died of acute renal failure. In 2015, the patient underwent surgery for gastric cancer. The reporting physician classified the event, acute renal failure, as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: On 25Apr2021, the patient received the vaccine and developed adverse reaction, which disappeared in a few days. More than 10 days later, the events occurred; thus, direct causality between the events and the vaccine was considered to be low. The case was reported just in case because there was abnormality in coagulation system. The patient underwent lab tests and procedures which included body temperature: 36.3 Centigrade on 25Apr2021 (before vaccination). Therapeutic measures were taken as a result of DVT. The clinical outcome of the event, visual acuity reduced, was recovered on 29Apr2021. The clinical outcome of the events: DVT, weakness generalized, and dehydration was unknown. The clinical outcome of the event, acute renal failure, was fatal. The patient died on 12May2021 due to acute renal failure. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: Acute renal failure


VAERS ID: 1428985 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Drowning, Drug screen, Investigation, Troponin
SMQs:, Drug abuse and dependence (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: before vaccination; Test Date: 202106; Test Name: Urine drug; Test Result: Negative ; Comments: autopsy; Test Date: 202106; Test Name: Cyan in oral cavity; Test Result: Negative ; Comments: autopsy; Test Date: 202106; Test Name: Spinal fluid; Result Unstructured Data: Test Result:colorless like water; Comments: autopsy; Test Date: 202106; Test Name: Myocardial troponin test; Test Result: Positive ; Comments: autopsy
CDC Split Type: JPPFIZER INC2021691238

Write-up: This is a spontaneous report from a contactable physician. Regulatory authority report number is v21113722. The patient was an 88-year and 1-month-old female. On 06Jun2021 at 15:33 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration at age of 88-year-old as a single dose for COVID-19 immunization. Body temperature before vaccination was 37.2 degrees centigrade. Family history was not reported. Medical history included diabetes mellitus, dyslipidaemia, and late effects of cerebral infarction. The patient''s concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunisation. On 07Jun2021 from around 20:00 to 24:00 (estimation) (1 day after the vaccination), the patient experienced drowning during bathing. On 07Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient lived alone, supported herself, and worked in fields a little. The patient normally visited another hospital (for diabetes mellitus, dyslipidaemia, late effects of cerebral infarction, and others). On 07Jun2021 in the morning, the patient served a gardener a cup of tea (when the patient was last seen). On 09Jun2021, a neighbor didn''t see the patient and became suspicious, for which the neighbor visited the patient and found the patient submerged in bathtub and dead at home. Subsequently, autopsy was conducted by the police and the reporting physician witnessed the examination. Findings included decomposition coloration of the trunk, chest compression, manifestation of bubbles in the oral cavity, and swelling and desquamation of the skin of hands and feet. On the other hand, no abnormality was observed in spinal fluid which was colorless like water, drug in urine which was tested was negative, and cyan in oral cavity which was tested negative. Myocardial troponin test was positive but was not taken into account (according to the investigation by the police). Based on the above, it was considered as death due to asphyxia by aspirating water. 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 the presence of multiple underlying diseases. The reporting physician commented as follows: Cause of drowning was unknown. ; Reported Cause(s) of Death: drowning during bathing; asphyxia by aspirating water; Autopsy-determined Cause(s) of Death: asphyxia by aspirating water


VAERS ID: 1428986 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Headache, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 17
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: Arrhythmia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Egg allergy; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021691353

Write-up: many times of vomiting; cold sweat; generalised malaise; Headache; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21113665. The patient was a 65-year and 9-month-old female. Body temperature before vaccination was 36.1 degrees Centigrade. The patient''s family history was not reported. The patient''s medical history included ongoing arrhythmia (underlying disease), atrial fibrillation (there was description of atrial fibrillation in the medical record when the patient had visited the reporter''s hospital before). The patient''s allergy history includes raw egg which had caused urticaria and previously received acetylsalicylic acid (BUFFERIN) and experienced any allergy symptom(s). On an unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# and Expiration date unknown) for COVID-19 immunization. On 18May2021 at 10:12 (the day of vaccination) at the age of 65-year-old, the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19May2021 at night (the day after the vaccination), the patient experienced headache. The outcome of the event was unknown. On 20May2021 at 06:30 (2 days after the vaccination), the patient experienced many times of vomiting, cold sweat, generalized malaise. On the same date, the patient was admitted to the hospital. On 05Jun2021 (18 days after the vaccination), the outcome of the event was fatal (Information gave verbally from the patient''s family). The course of the event was as follows: On 18May2021 at 10:12 (the day of vaccination), the patient received the second dose of BNT162B2. On 19May2021 at night (the day after the vaccination), headache was noted. On 20May2021 at 06:30, the patient had frequent vomiting, cold sweat and generalized malaise after taking shower. Therefore, the patient was urgently transported to the hospital. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162B2 as unassessable (difficult to assess). Other possible cause of the events such as any other diseases was reported as: stroke due to atrial fibrillation, etc. The patient died on 05Jun2021 (the cause of death was not reported). It was not reported if an autopsy was performed. The reporting physician commented as follows: The causal relationship between the side reactions and BNT162B2 could not be determined considering the patient''s past medical history (atrial fibrillation).; Reported Cause(s) of Death: many times of vomiting; cold sweat; generalised malaise


VAERS ID: 1428988 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood pressure measurement, 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: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; LASIX [FUROSEMIDE]; SPIRONOLACTONE; CILNIDIPINE; ALLOPURINOL; SARPOGRELATE; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (She received the treatment Apr2009); Arteriosclerosis obliterans (She received the treatment Apr2009); Arteriosclerosis obliterans; Cardiac failure (She received the treatment Apr2009); Chronic kidney disease (She received the treatment Apr2009); Dementia (She received the treatment Apr2009); Dyspnoea (required hospital treatment); Femoral neck fracture (She received the treatment Apr2009); Hypertension (She received the treatment Apr2009); Left heart failure (required hospital treatment); Osteoarthritis of lumbar spine (She received the treatment Apr2009)
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/66; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021692033

Write-up: Cardio-respiratory arrest; Apnoea; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The report is also received from the Regulatory authority via regulatory authority report. RA number is v21113132. The patient was a non-pregnant 87-year and 1-month-old female. Since Apr2009, the patient had received the treatment for hypertension, cardiac failure, chronic kidney disease, anaemia, dementia, osteoarthritis of lumbar spine, status after femoral neck fracture and arteriosclerosis obliterans. The patient was emergently hospitalized for dyspnoea due to left heart failure in Jul2020, and then the presence of arteriosclerosis obliterans was pointed out. While she was using a day-care facility located next to the reporter''s hospital, she was regularly visiting the reporter''s hospital once a month. The patient had no relevant family history. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received enalapril, furosemide (LASIX), spironolactone, cilnidipine, allopurinol, sarpogrelate, lansoprazole within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Jun2021 at 10:50 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 09Jun2021 at 18:00 (the day of vaccination), the patient experienced Apnoea which resulted in death. On 09Jun2021 at 19:30 (the day of vaccination), the patient experienced cardio-respiratory arrest which resulted in death. An autopsy was not performed. Additional clinical course was reported as follows: On 09Jun2021, the reporter visited the patient on the day of once-a-week day-care service (the reporter adjusted his schedule). At 09:15, the reporter arrived at the daycare facility, and at 10:50, the reporter gave the vaccination to the patient. At the time of the vaccination (before the vaccination), body temperature was 35.8 degrees Centigrade and blood pressure was 136/66. The reporter observed the patient until the time when the day care service was finished, and during the time, no change was noted in her condition. After a facility member sent her to her house, her care manager visited her house from 17:00 to 17:30, and during the time, her son was talking to the care manager about rental of a welfare equipment such as portable latrine, but there was no change. At 18:00, a staff member received the phone call from her son saying that she might not breathe. Thus, immediately, an emergency service was requested to transfer the patient to a hospital. She was transferred to the hospital by an ambulance. At 19:30, the patient''s death was pronounced. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Possible cause of the event was reported as follows: In 2020, the patient was emergently hospitalized for dyspnoea due to left heart failure, therefore, there was a possibility that cardiac failure caused the occurrence of cardio-respiratory arrest.; Reported Cause(s) of Death: Cardio-respiratory arrest; Apnoea


VAERS ID: 1429014 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased to some extent
CDC Split Type: JPPFIZER INC2021693577

Write-up: Respiratory failure; Renal failure; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21113660. The patient was a 96-year and 4-month-old female. Body temperature before vaccination was not reported. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 01Jun2021 at around 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 15:00 (around 1 hour 30 minutes after the vaccination), the patient experienced respiratory failure and renal failure. On 02Jun2021 in the morning (1 day after the vaccination), the patient was admitted to the hospital. On 05Jun2021 (4 days after 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: On 01Jun2021 at around 13:30, the patient received the second dose of the vaccine. Just after 15:00, the patient had large amount of stools and blood pressure decreased to some extent, for which the patient received infusion. The patient ate supper as usual. At midnight, respiratory status aggravated and on 02Jun2021 in the morning, the patient was emergently admitted to a hospital. The patient was diagnosed with respiratory failure and renal failure and hospitalized. The patient received infusion and was placed on a ventilator; however, general condition gradually aggravated. On 05Jun2021, death was confirmed. The reporting physician classified the event as serious (life-threatening) 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 patient was of advanced age and causality between the events and the vaccine was unknown.; Reported Cause(s) of Death: Respiratory failure; Renal failure


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