Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
vascular retinopathy; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (gotten at least two or three COVID shots/boosters, unknown manufacturer), for Covid-19 immunization. The following information was reported: RETINAL VASCULAR DISORDER (disability, medically significant) with onset 01Dec2023 at 11:00, outcome "unknown", described as "vascular retinopathy". The event "vascular retinopathy" required physician office visit. Therapeutic measures were taken as a result of retinal vascular disorder. The patient stated that she had gotten at least two or three COVID shots/boosters before she was diagnosed with vascular retinopathy and her and doctor believe it was brought on by one of the COVID vaccines. Pharmacy only has record of one of these doses, so it was unknown the exact timeline of events. The patient reported she has to get painful shots in her eyes from her doctor every 3 months. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event retinal vascular disorder with COMIRNATY (2023-2024 FORMULA) can not be fully excluded. 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.