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Life Threatening? No
Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-AN20210164. An 86-year-old male patient received bnt162b2 (COMIRNATY) , intramuscular at single dose on 06Jan2021 for Covid-19 immunisation (in comfort care for months). Medical history included cataract bilateral nos and prostate adenoma. Concomitant medications were not reported. The patient experienced death unexplained on 27Jan2021. Course of the event as follows: Around 20Jan2021, deterioration of the general condition. Rapidly progressing renal failure managed in a palliative manner. Patient died on 27Jan2021. An autopsy was not performed. Declaration of pharmacovigilance in principle, not related to the supposed vaccination because pre-existing severe condition. The patient underwent lab tests and procedures which included Creatinine (?mol / L): 153 (14Dec2020), 176 (08Dec2020), 22 (23Dec2020), 255 (30Dec2020), 258 (06Jan2021) 343 (13Jan2021); Leukocytes (G / L) 9.84 (30Dec2020), 6.11 (06Jan2021), 7.58 (13Jan2021); Hemoglobin (g / dL): 10.7 (30Dec2020), 9.6 (06Jan2021), 3.04 (13Jan2021); CRP: <4mg / L on 06Jan2021; PCR SARS-COV 2 undetectable on 31Dec2020. No follow-up attempts possible. No further information expected, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the event Death unexplained is most likely related to an intercurrent or underlying condition which is not related to the suspect product BNT162B2. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Death unexplained
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