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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
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