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Life Threatening? No
Write-up: GM seizures; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is HU-OGYI-384721. A 76-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 01May2021 (Batch/Lot Number: EX6537) as dose 2, 0.3mL, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypoacusis and dementia. He was nursed at his home for several years. He was also treated on neurology in 2020. September due to suspected epileptic seizure. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 (Batch/Lot Number: ET7205) for COVID-19 immunisation. On 17May2021, the patient had grand mal convulsion (GM seizures). He was submitted to hospital on 17May2021 and died on 23May2021. It was unknown if autopsy was performed. Sender Comment: Grand mal convulsion is not an expected adverse event of COMIRNATY. TTO was 16 days. The patient had suspected epileptic seizure in Sep2020, as well. Based on the above, causality between grand mal convulsion and COMIRNATY is unlikely. No further information is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: GM seizures
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