Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015179 | — |
No additional AE/no PQC; experienced two temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant therapies was not reported. On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as prefilled syringe formulation, at a dose of 0.5ml (lot #Y015179 who had been verified to be a valid lot number, expiration date reported and validated as 28-JAN-2027). The vaccine was administered as prophylaxis. On 14-JUL-2025, the vaccine experienced two temperature excursions. Temperature reported 47.3F with a time frame of 0 hours 50 minutes and 24 seconds, there was a previous temperature excursion of 47.5F for 0 hours 36 minutes and 51 seconds (Product storage error). No additional adverse event.