Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012508 | — |
No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a temperature excursion.; This spontaneous report was received from a medical assistant on 12-Aug-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-AUG-2025, the patient was vaccinated with an improperly storage dose of) with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), prefilled syringe (lot #Y012508, expiration date not reported, but upon internal validation established as 01-Jan-2027), frequency: total after temperature excursion for Prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 2.9 grade Fahrenheit for 5 minutes. No additional adverse event reported. This is one of several reports received from the same reporter (case # 2319351).