Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013818 | — |
No additional AE; improper stored vaccine adnimistered; This spontaneous report was received from medical assistant and referred to a 9-year-old patient of unknown gender. The patient had no illness at vaccination, no pre-existing physician-diagnosed allergies or birth defects medical conditions. The patient's past medications were not reported. The patient's concomitant medications were not reported. It was reported that a Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) stored in clinical practice (lot # Y013818, expiration date 12-Feb-2027) experienced a temperature excursion of 34.3F for 3 hours 57 minutes 30 seconds on 02-Oct-2025, and a temperature excursion of 34.7F for 7 hours 45 minutes on 15-Oct-2025. The temperature excursion occurred as a result of a reading from a digital data logger. On 23-Oct-2025, the patient was vaccinated with the improper stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (0.5 mL; strength and route of administration were not provided) for prophylaxis at a private doctor's office (product storage error). No additional AE (no adverse event) was reported. The outcome of product storage error was reported as recovered. The reporter considered product storage error to be related to suspect vaccines but determined to be not assessed per internal guidelines. This is one of several cases from the same reporter.
Comments: no illness at vaccination, no pre-existing physician-diagnosed allergies, birth defects medical conditions