Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac event leading to death; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 89-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 at 15:00 as dose 4, (booster) 0.3 ml single (Lot number: FK9896) at the age of 89 years intramuscular, in left deltoid for covid-19 immunisation. Concomitant products, medical conditions, tests: Nothing within two weeks. Patient did have a history of dementia, hypothyroidism, hypokalemia, and osteoporosis, which was age related. Confirms all of these were prior to the patient receiving the vaccine. Patient not received additional vaccines administered on same date of the Pfizer suspect. Vaccination history included: comirnaty (Dose 3 (Booster) , single, Lot number: 30130BA, Expiration date: unknown, NDC number: unknown, Dose and route: 0.3ml, left deltoid, intramuscular), administration date: 07Oct2021, for Covid-19 immunization; Comirnaty (Dose 1, single, NDC number, lot number, expiration date: unknown), for Covid-19 immunization; Comirnaty (Dose 2, single, NDC number, lot number, expiration date: unknown), for Covid-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 12Apr2022 at 20:00, outcome "fatal", described as "cardiac event leading to death". The patient date of death was 13Apr2022. Reported cause of death: "Cardiac event leading to death". It was not reported if an autopsy was performed.  Clinical course: Reporter stated about Comirnaty, also known as the Pfizer COVID-19 vaccine. Calling in two parts, to report an adverse event for a patient and to see if the adverse event has been reported before and to see how prevalent the adverse event was. Patient was vaccinated 12Apr2022, monitoring was done, and the next day, 13Apr2022, the facility called and said the patient had expired. Cause of death: Unknown, the facility was not specific outside of calling the event a cardiac event. This was the patient's 2nd booster, confirms this was the 4th dose for the patient. Caller does not have all of the specific of dates and lot numbers but was aware that all 4 doses were the Pfizer COVID-19 vaccine. The patient's 3rd and 4th dose were administered by caller's pharmacy. Reporter not aware of exact time, but believes the cardiac event have been after 8PM 12Apr2022, that's the last time the pharmacy staff was at the facility and the event had not occurred yet. It was unknown whether the patient was hospitalized and how many days was in hospital. Reporter was not aware any prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and any adverse event as well.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac event leading to death