Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | Y010466 | — |
No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a temperature excursion; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 11-AUG-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection, administered for prophylaxis (lot number Y010466 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 29-OCT-2026; dose number, route of administration and anatomical site of injection were not provided). The vaccine was administered after a temperature excursion (TE) at 2.9 degree Fahrenheit (F) for 5 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient. This is one of two reports from the same reporter.