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Life Threatening? No
Write-up: Intra-cerebral haemorrhage; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20212305, Safety report unique identifier FR-AFSSAPS-2021075527. A 29-year-old male patient received bnt162b2 (COMIRNATY) at the age of 29-year-old, dose 1 intramuscular on 10Jun2021 (Batch/Lot Number: EX7823) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced intra-cerebral haemorrhage on 12Jun2021. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: 29-year-old male patient who presented with a cerebromeningeal hemorrhage two days after the first dose of COMIRNATY lot EX7823. The patient had no medical history, we noted a jogging session the day before the event, on 11Jun. On 12Jun, at home feeling unwell in the toilets with cardiopulmonary arrest. He was brought to the emergency room, diagnosed with cerebromeningeal hemorrhage with commitment. The declaring doctor suspected a ruptured aneurysm, but did not rule out the hypothesis of a surge in blood pressure following the vaccination. He died as a result of this hemorrhage. Time Interval between Beginning of Drug Administration and Start of Reaction / Event 3 days Did reaction recur on readministration? (NO -- N/A (no rechallenge was done, recurrence is not applicable)) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Intra-cerebral haemorrhage
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