Received Apr 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
'mini-stroke'. She was hospitalized for 3 days; slurred speech; VACCINE GAP ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 71-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 71 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: TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 31Oct2022, outcome "unknown", described as "'mini-stroke'. She was hospitalized for 3 days"; DYSARTHRIA (hospitalization) with onset 31Oct2022, outcome "unknown", described as "slurred speech". The patient was hospitalized for transient ischaemic attack, dysarthria (start date: 2022, discharge date: 2022, hospitalization duration: 3 day(s)). The events "'mini-stroke'. she was hospitalized for 3 days" and "slurred speech" required emergency room visit. Clinical course: Patient reported that 2 days after getting COVID vaccine, she noticed she had slurred speech. She went to the hospital and was diagnosed with 'mini-stroke'. She was hospitalized for 3 days. And because of that she has decided to not get COVID vaccine anymore. The reporter's assessment of the causal relationship of "'mini-stroke'. she was hospitalized for 3 days" and "slurred speech" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the available information, the causal association between the events Transient ischemic attack, dysarthria and the suspect product BNT162b2 can not be excluded. 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.