Received Feb 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Covid vaccine was what caused her autoimmunity issue; This is a solicited report received from a Consumer or other non HCP from medical information team, Program ID: . A 28-year-old 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Covid vaccine was what caused her autoimmunity issue". Clinical course: a patient, would like to know if there is anything in Ruxience that was also in the Covid Vaccine as the patient feels the Covid vaccine was what caused her autoimmunity issue. Patient was set to get Ruxience and doesn't think that the COVID vaccine sat right with her. Asking if there is anything in the vaccine that's in Ruxience. Patient would like to compare the ingredients between Ruxience and the 25/26 Pfizer COVID-19 vaccine. The reporter considered "covid vaccine was what caused her autoimmunity issue" related to BNT162b2 omicron (lp.8.1). 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 autoimmune disorder 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.