Received Jun 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0846 | OT / RA |
Patient received vaccine that was stored incorrectly; stored in the regular freezer, temperature range: -12.2 F to -8.2 F; Patient received vaccine that was stored incorrectly; stored in the regular freezer, temperature range: -12.2 F to -8.2 F; This is a spontaneous report received from nurses and other healthcare professionals from medical information team, Program ID. A 10-year-old female patient received BNT162b2 Omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Jun2026 at 17:12 as dose 1, 0.3 ml single (Lot number: NA0846, Expiration Date: 30Nov2026) at the age of 10 years intramuscular, in right deltoid for COVID-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 01Jun2026 at 17:12, outcome "unknown" and all described as "Patient received vaccine that was stored incorrectly; stored in the regular freezer, temperature range: -12.2 F to -8.2 F". Additional Information: The nurse wanted to know if the Comirnaty 2025-2026 formula (UPC Number: PAA240613, NDC Number: 0069-2501-01) received in dried ice is still viable. Administered to a patient. The patient received vaccine that was stored incorrectly, vaccine was administered on 01Jun2026. Per nurse, the vaccine vials arrived on dry ice, they thought that the instructions have said to store vaccine in the freezer and was placed or stored in the regular freezer (they also realized that was incorrect vaccine). Since 06May2026, the nurse was asking if vaccine is still viable, temperature range: -12.2 F to -8.2 F. That was the only patient that received vaccine from that freezer.
Medical History/Concurrent Conditions: Allergy
ZYRTEC [CETIRIZINE HYDROCHLORIDE]