Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Haemorrhage intracranial
Clinical narrative: He died of an intracranial bleed; He was thrown into afib and they coded him on day shift; This is a spontaneous report received from an Other HCP from medical information team.  A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Morbid obesity" (unspecified if ongoing); "type 2 Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Molnupiravir; Covid-19 vaccine for Covid-19 immunization, notes: Dose number: 1 & 2, Unknown manufacturer; Covid-19 vaccine for Covid-19 immunization, notes: Dose number: 3 & 4, Primary immunization completed, Unknown manufacturer; Remdesivir; Decadron . The following information was reported: HAEMORRHAGE INTRACRANIAL (death, hospitalization, medically significant), outcome "fatal", described as "He died of an intracranial bleed"; ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "He was thrown into afib and they coded him on day shift". The patient date of death was unknown. Reported cause of death: "He died of an intracranial bleed". It was not reported if an autopsy was performed.  Clinical course: Patient is morbidly obese with comorbidities and they treated him with Remdesivir, Decadron and does not know whether he will have Covid Pneumonia but he does know he just started on Remdesivir. He is a type 2 Diabetic. He confirmed that he did not see any evidence in the patient's chart that he had received a Covid vaccine. The caller explained that he just had a 71 year old (a different patient) that received the latest dose of the Comirnaty vaccine and this gentleman got a script for Molnupiravir and he came to them (the hospital) because he was thrown into afib and they coded him on day shift and he went to the ICU and he died of an intracranial bleed. There is a lot of concern and apprehension about receiving the vaccine. He received every successive shot and injective dose of the vaccine so the caller did not think it had anything to do with it. He thinks it was an underlying factor that eventually came to fruition. The caller does not believe it is related to the vaccine. For this patient age 71 year old patient, he has no lots, expiry dates or NDC numbers for the patient's Pfizer covid vaccines to provide or for the most recent Comirnaty vaccine and states he works on a busy med surg unit and had 11 patients that day. The information for the 71 year old patient did not show up in triage information but he knows the patient received all Pfizer Covid19 vaccines and the most recent one of the Comirnaty.     The reporter considered "he died of an intracranial bleed" and "he was thrown into afib and they coded him on day shift" not related to BNT162b2 omicron (kp.2).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event haemorrhage intracranial, and atrial fibrillation; and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: He died of an intracranial bleed