Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
facial muscle paralysis; got really sick from the vaccine; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 2025, outcome "unknown", described as "facial muscle paralysis"; ILLNESS (non-serious) with onset 2025, outcome "unknown", described as "got really sick from the vaccine". Therapeutic measures were taken as a result of facial paralysis. Clinical course: During call reporter stated that over the past month she has a friend, she got really sick from the vaccine. Employers made them get it. It is stated that because of that patient have facial muscle paralysis. She couldn't recall the name of the vaccine. She had surgery and she looks like a completely different person now. Caller stated that was the Covid vaccine, but she doesn't know if it was Pfizer or redacted. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded for the reported events. The detailed information would be helpful for further assessment. The case will be reassessed based on the follow-up information. 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.