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Life Threatening? Yes
Write-up: Hypoxic Brain Injury; Dilated cardiomyopathy; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Safety Report Unique Identifier GB-MHRA-ADR 25000301. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243, expiration date was not reported), via an unspecified route of administration on 13Feb2021 at single dose for covid-19 immunization. Medical history included H hernia. It was reported that patient has no major medical issues other than H hernia. Patient has not had symptoms associated with COVID-19, and was not enrolled in clinical trial. Concomitant medication included lansoprazole for hiatus hernia. The patient experienced cardiac arrest on 23Feb2021 (also reported as 23Mar2021). The clinical course was reported as follows: patient was taken to A&E (accident and emergency) with an out of hospital cardiac arrest on 23Feb2021 (also reported as 23Mar2021) 10 days after vaccination, patient was admitted to ITU (Intensive Therapy Unit). Coronary angiogram was clear, CT head normal. Death reported as due to hypoxic brain injury, cardiac arrest, and dilated cardiomyopathy. Patient had no prior cardiac history. This may of course be unrelated to the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no - negative covid-19 test) on 27Feb2021. The patient died on 02Mar2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: In concurrence with the reporting investigator, the Company deems the reported cardiac arrest occurred 10 days after the administration of COVID19 vaccine, BNT162N2, unlikely related to the suspect. Similarly, hypoxic brain injury and dilated cardiomyopathy are unrelated to the suspect.; Reported Cause(s) of Death: Hypoxic Brain Injury; Dilated Cardiomyopathy; Cardiac arrest
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