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Write-up: Cerebral haemorrhage; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21109405. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11May2021 at 13:27 (Batch/Lot Number: EY2173; Expiration Date: 31Aug2021) at 85-years-old as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic cardiac failure, cerebellar infarction, chronic kidney disease, hypertension, emphysema; all from an unknown date and unknown if ongoing. Concomitant medications included furosemide (MANUFACTURER UNKNOWN); amlodipine (MANUFACTURER UNKNOWN); lansoprazole (MANUFACTURER UNKNOWN); apixaban (ELIQUIS); isosorbide mononitrate (ITOROL); theophylline (THEODUR); all taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunisation on 20Apr2021 at 9 decades old (as reported) (at 13:16, dose 1, Lot Number: ER7449, Expiration date: 30Jun2021). On 22May2021 19:10, the patient experienced cerebral haemorrhage (death, medically significant), and cardio-respiratory arrest (medically significant) requiring an emergency room visit. The clinical course was reported as follows: The patient was an 85-year-old male. Body temperature before vaccination was 35.6 degrees Centigrade. Family history was not reported. Medical history included atrial fibrillation, chronic cardiac failure, cerebellar infarction, chronic kidney disease, hypertension, and emphysema. The patient had no history of allergy. Concomitant medications included furosemide, amlodipine, lansoprazole, apixaban (ELIQUIS), isosorbide mononitrate (ITOROL), and theophylline (THEODUR). On 20Apr2021 at 13:16, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021). On 11May2021, at 13:27 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 22May2021 at 19:10 (11 days, 5 hours and 43 minutes after the vaccination), the patient experienced cerebral haemorrhage. On 22May2021 at 20:30 (11 days, 7 hours and 3 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 22May2021 at 19:10 (11 days, 5 hours and 43 minutes after the vaccination), the patient was found in cardio-respiratory arrest at home. While receiving resuscitative measures, the patient was emergently transported to the hospital. Computerised tomogram (CT) showed cerebral haemorrhage. Resuscitation was unsuccessful, and the patient was confirmed dead at 20:30. The reporting physician classified the event cerebral haemorrhage as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases was reported as follows: the patient had hypertension and atrial fibrillation, for which anticoagulant treatment was being performed. The reporting physician commented as follows: In this case, the patient experienced cerebral haemorrhage on Day 11 after the BNT162b2 vaccination. Since the patient had underling diseases, the causality between the event and BNT162b2 was unknown. However, since the event occurred within a relatively short period of the vaccination, this case was reported. The patient underwent lab tests and procedures which included body temperature: 35.6 Centigrade on 11May2021 (before vaccination), CT: cerebral haemorrhage on 22May2021. Therapeutic measures were taken as a result of cardio-respiratory arrest. The clinical outcome of the event, cardio-respiratory arrest, was unknown. The clinical outcome of the event, cerebral haemorrhage, was fatal. The patient died on 22May2021 due to cerebral haemorrhage. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cerebral haemorrhage
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