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This is VAERS ID 1428860

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First Appeared on 7/2/2021

VAERS ID: 1428860
VAERS Form:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other      Purchased by: ??
Symptoms: Cardiac death, Coronavirus test

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-06-10
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Myocardial infarction; Stent placement
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

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