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Write-up: his face looked pale; blood pressure decreased (90s); High hepatic function disorder; Liver function test increased; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. The patient was an 84-year-old and 10-month-old male. The patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) was none. While it''s also reported medical history cerebral infarction (right paralysis). Body temperature was 35.4 C before vaccination. On 31May2021 at 16:00 (the day of vaccination, at 84-year-old), the patient received the first single dose of BNT162B2(COMIRNATY, intramuscular injection, Lot number: EY5420, expiration date: 31Aug2021) via unspecified route of administration for COVID-19 immunization. There were no adverse events until 04Jun2021. At 19:30 on 04Jun2021 (4 days after the vaccination), when the patient was eating in a nursing facility (dining hall), his face looked pale, the patient was moved in a wheelchair, blood pressure decreased (90s), so he was moved to the bed to lie down. The blood pressure was measured later, the blood pressure was recovered to 105. Also, blood test was performed and it showed that liver function test increased (GOT 2933, GPT1530, ALP 744, ?-GTP 433). Judging from the results of the blood test at that time, it was high hepatic function disorder. Prescription drugs included amlodipine 2.5mg, clopidogrel 75mg, lansoprazole. The patient did not received amlodipine, clopidogrel, lansoprazole as of initial report on 04Jun2021. The meal, the drip was stopped and other supplement was not received at present. The outcome of the event was reported as recovering. The reporter classified the event as serious (hospitalized from 21Feb2021) (the patient had already been hospitalized) and the causality between the event and the vaccines was not provided. Other possible cause of the event such as any other diseases was it might be related to internal medicine. The reporter comments as follows: Although it was considered as a side effect of the vaccine, it was still unknown.; Sender''s Comments: Based on the available information, the causal association between the reported events (liver function test increased, pallor facial, blood pressure decreased and hepatic function disorder) and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up 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.
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