Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y010656 | — |
No additional AE/PQC.; HCP called and reported inadvertent administration of GARDASIL 9 after a temperature excursion that occurred on 18MAR2025. GARDASIL 9 was administered on 19MAR2025 to a patient. Limited demographics provided. No additional AE/PQC. No additional infor; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 mL per dose (valid lot number Y010656, expiration date 29-NOV-2026) (dose number, vaccination scheme, frequency, anatomical location, route of administration was not provided) for prophylaxis, after a temperature excursion of -0.6 degrees Celsius, with a time frame of 25 hours 0 minutes 0 seconds that occurred on 18-MAR-2025. No previous temperature excursion. No additional adverse event (AE) reported.