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Life Threatening? No
Write-up: The gentleman died approximately 38 hours after vaccination. He suffered from mental retardation and epilepsy; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB (NL-LRB-00460038). A 39-year-old male patient received BNT162B2 (COMIRNATY; lot number EK9788) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included mental disability, familial hypercholesterolaemia, epilepsy, pre-term birth, cortical damage and fetal distress. The patient suffered from mental retardation and nocturnal epilepsy, based on cortical damage and pre-term birth (8 weeks)/fetal distress. Another cause for mental retardation was never confirmed. Nocturnal epilepsy was treated by the neurologist. Patient was residing in an institution. The patient had an alarm system for nocturnal epilepsy that worked well. Concomitant medications included colecalciferol 5600 IU, ezetimibe strength 10 mg, rosuvastatin strength 10 mg, lamotrigine 50 mg twice daily and valproate sodium (DEPAKINE ENTERIC) at 1000 mg twice daily. The patient died on 27Feb2021, approximately 38 hours after vaccination. He suffered from mental retardation and epilepsy. An autopsy was not performed. Prior to his death, the patient had no other complaints and no fever. No obduction was done. LDL values were under control and there was no sign of any cardiovascular issues due to his familial hypercholesterolaemia. The patient was in a good state the days prior to the vaccination. The vaccination was decided after consultation with the neurologist. After vaccination, there was nothing out of the ordinary, no complaints or symptoms. The evening before death the patient was in a good state, was happy and extensively called with the parents through video call. Because the patient had not woken up at 7.30, at 8.00 one had a look and one found the patient dead in bed. Was still warm, but rigor mortis already started. A bit of foam was visible on the mouth. There were no other things out of ordinary. Unclear if there is a relationship with the vaccination. The patient suffered from mental retardation and epilepsy after an extremely pre-term birth. Additionally, there was familiar hypercholesterolemia. He was treated by the neurologist. Using lamotrigine and depakine he had persistent nocturnal attacks which were stable. The patient was found on 27Feb2021 dead in bed. The patient did not have complaints the day before, no fever. There has been discussion with the neurologist. There was no strict contra-indication for vaccination. The relationship with the vaccination and passing away has not been confirmed and it is not possible confirm afterwards. It has been decided to not choose to have an obduction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
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