Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
OMAS (opsoclonus-myoclonus-ataxia syndrome); This is a spontaneous report received from a Physician. A 77-year-old female patient (not pregnant) 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 included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took rheumatoid arthritis medications. The following information was reported: OPSOCLONUS MYOCLONUS (medically significant), outcome "unknown", described as "OMAS (opsoclonus-myoclonus-ataxia syndrome)". It was unknown if therapeutic measures were taken as a result of opsoclonus myoclonus. 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: As there is limited information in the case provided, the causal association between the event opsoclonus myoclonus and the suspect drug BNT162B2 OMICRON (LP.8.1) 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.
Medical History/Concurrent Conditions: Rheumatoid arthritis