Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | HN0477 | OT / RA |
Meibomian gland dysfunction; Eye swelling; Leg pain; They were stored in the refrigerator and the expiration date on the box was May 4, 2024. It was inadvertently given to patients on May 6 and May 7, 2024; This is a spontaneous report received from Nurses and Other HCPs from medical information team, Program ID. A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06May2024 as dose 1, 0.3 ml single (Lot number: HN0477, Expiration Date: 04May2024) at the age of 63 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 06May2024, outcome "unknown", described as "They were stored in the refrigerator and the expiration date on the box was May 4, 2024. It was inadvertently given to patients on May 6 and May 7, 2024"; MEIBOMIAN GLAND DYSFUNCTION (non-serious), outcome "unknown"; EYE SWELLING (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain". Additional information: The Pfizer covid 19 vaccine in glass prefilled syringes for 12 and older were stored in the refrigerator and the expiration date on the box was 04May2024. It was inadvertently given to patients on May 6 and May 7, 2024. There were 4 patients total. NDC 00069-2377. Follow-up (15Jun2024): Follow-up attempts are completed. Follow-up (05Dec2025): This is a spontaneous follow-up report received from Other HCP. Updated information includes: reporter information and reaction data (added events meibomian gland dysfunction, eye swelling, and leg pain).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400106024 same drug, similar event, different patients; US-PFIZER INC-202400106023 same drug, similar event, different patients; US-PFIZER INC-202400106025 same drug, similar event, different patients;
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None