Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013818 | — |
no adverse event; Improper storage of product in use; This spontaneous report was received from a physician assistant and refers to a 9-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Oct-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9), 0.5 mL, lot # y013818 upon internal validation process was established as Y013818, expiration date: 12-Feb-2027 for prophylaxis (route of administration and anatomical location were not reported). Temperature excursion occurred as a result of a reading from a digital data logger. No adverse event was reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-12-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-12-11 , Classification : , Attachment description : Minimal Data Entry , Safety case number :