Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
CKD; diabetes; Couldn't walk well; sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "CKD"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "Couldn't walk well"; ILLNESS (non-serious), outcome "recovered", described as "sick". Clinical course: The following events were reported: Couldn't walk well after COVID-19 booster vaccine. Was sick for 12 days. Felt that diabetes treatment caused CKD. Unknown which diabetic treatments received, unsure if it was a Pfizer treatment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.