Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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 "not recovered", described as "autoimmune disease". Clinical course: Patient inquired about the appropriate waiting period before receiving the 2025/2026 COVID-19 vaccine after having received the 2024/2025 dose on 12Aug (year unspecified), patient has autoimmune disease, and her doctor is recommending she get the new one. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.