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Life Threatening? No
Write-up: Sudden death unexplained; This is a spontaneous report from a contactable physician. This is a report received from Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number was GB-MHRA-ADR 24619825 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-202101201100194950. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK1768), via an unspecified route of administration on 16Jan2021 as a single dose for COVID-19 immunization. Medical history included immunodeficiency (an illness or condition which reduces the immune response), poorly controlled diabetic (HbA1c in Apr2020 was 80), mental illness, and unkempt individual with concerns of self-neglect. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), and nitrazepam (MANUFACTURER UNKNOWN). On an unknown date in Jan2021, the patient experienced sudden death unexplained. The clinical course was as follows: The patient came in for the vaccination and was not overtly unwell. He was observed for 15 minutes following the vaccination. On 20Jan2021, the patient was found dead by police and had been transferred to the coroner. It was not confirmed if an autopsy was going to be performed. At the time of reporting, there was no clear evidence as of yet to link the vaccination and death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained
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