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Life Threatening? No
Write-up: death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was an 86-year-old male. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had ongoing medical histories of hypertension and renal impairment. The ongoing concomitant medications included ALFACALCIDOL capsule at 0.5 ug, daily; ambroxol hydrochloride sustained-release OD-tablet (Orodispersible tablet) at 45 mg, daily; DUTASTERIDE capsule 0.5 mg, at 0.5 mg daily; SILODOSIN tablet 4mg, at 8 mg, daily; ELIQUIS tablet, 5 mg, daily; magnesium oxide 330mg, at 660 mg, daily; amlodipine besilate (AMLODIPINE), tablet at 5 mg, daily; candesartan cilexetil (CANDESARTAN) 4mg, at 8 mg, daily; polystyrene sulfonate calcium, granules 89.29%, at 5.6 g, daily; bupleurum falcatum root, glycyrrhiza spp. root, magnolia spp. bark, panax ginseng root, perilla frutescens var. crispa herb, pinellia ternata tuber, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var. inermis fruit (SAIBOKUTO) extra granules TSUMURA (for medical use), 5 g, daily; D-SORBITOL, oral solution, 75% at 60 mL, daily; Venlafaxine Hydrochloride (EFFEXOR SR), capsule, 75 mg, daily; ramelteon (ROZEREM), tablet 6 mg at 6 mg, daily; trazodone hydrochloride, tablet 25mg at 12.5 mg, daily; quetiapine fumarate (QUETIAPINE) tablet 12.5mg, 6.25 mg, daily. On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at age of 86 years as single dose for COVID-19 immunization. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination at the reporting clinic. Although the patient was scheduled to receive the second dose of BNT162b2 vaccination on 22Jun2021 (11 days after vaccination), it was contacted that the second dose of the vaccination was desired to be canceled. The reason was revealed as death. The date of death was unknown because it could not be heard from the patient''s family. The cause of death was also unknown. The patient had medical examination history in the reporting clinic 13 years ago. The underlying diseases included hypertension and renal impairment (these information was confirmed according to the medical record and the medical questionnaire for vaccination). The reporter''s comment was as follows; the causality with BNT162b2 was low, and the cause was unknown at this time. The underlying illness has been treated at another hospital, therefore no further information cannot be obtained. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is an elderly with a background of hypertension and renal impairment; the contributory role of these factors cannot be excluded. This case will be reassessed once 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: death
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