Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
brain bleed; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2022 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant) with onset 15Oct2022, outcome "unknown", described as "brain bleed". The event "brain bleed" required physician office visit. Clinical course: Per patient, she had brain bleed. She is able to get the vaccine, but has to be monitored carefully by her PBR. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The event cerebral haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.