Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | N/A | IM / UN |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
scleritis in her eyes about 12-14 days after receiving the Covid vaccine; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from a Pharmacist, Other HCPs and a Consumer or other non HCP, Program ID. A 38-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years and 7 months intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "skin and skin structure infection" (unspecified if ongoing), notes: skin structure infection. The patient's concomitant medications were not reported. The following information was reported: SCLERITIS (medically significant) with onset 22Jan2025, outcome "not recovered", described as "scleritis in her eyes about 12-14 days after receiving the Covid vaccine". The event "scleritis in her eyes about 12-14 days after receiving the covid vaccine" required physician office visit. Therapeutic measures were taken as a result of scleritis. Clinical course: The patient developed scleritis in her eyes about 12-14 days after receiving the Covid Vaccine on 10Jan2025 that required multiple specialists to diagnose and is a continual ongoing condition. She will not be getting the COVID vaccine again and has had to have multiple treatments to manage the condition. The patient is receiving ongoing treatments for the scleritis and has had prednisone and other medication. The reporter's assessment of the causal relationship of "scleritis in her eyes about 12-14 days after receiving the covid vaccine" with the suspect product(s) BNT162b2 omicron (kp.2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: The event scleritis is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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: Major depressive disorder; Skin infection (skin structure infection)