Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013818 | — |
no additional AE; improperly stored vaccine administered; This spontaneous report was received from medical assistant and refers to a 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-Oct-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y013818 with expiration date not reported but upon internal validation established as 12-Feb-2027) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis. The patient was vaccinated with an improperly stored vaccine (product storage error). Administered doses of suspect vaccines experienced the temperature excursion (TE) below 34.3 Fahrenheit degrees (F) for 3 hours 57 minutes 30 seconds on 02-OCT-2025, below 34.8 F for unknown at time of call, below34.7 F for 7 hours 45 minutes 0 seconds on 15-OCT-2025, below 35 F for unknown at time of call. The reporter called back, and TE was completed with another agent while this AE case was being worked on, TE case noted with caller stating that the two unknown dates/temps were a mistake, and that there were only two excursion dates. No previous temperature excursions reported. No additional adverse event was noted (no adverse event). No product quality complaints (PQC) were noted. This is one of several reports received from the same reporter.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : @merck.com , Index date : 2025-12-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Central date : 2025-12-11 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :