Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | y018297 | — |
No additional AE/No PQC; a PFS of GARDASIL 9 that was activated on 9/19/2025 was not discarded as recommended by end of day on 9/19/2025, and was inadvertently administered to a 9yr old on 9/22/2025.; This spontaneous report was received from a nurse and refers to a 9-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Sep-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe was activated, but was not discarded as recommended by the end of day. On 22-Sep-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled was inadvertently administered, at a dose of 0.5 mL (lot #y018297, expiration date: 13-Feb-2027) for prophylaxis (Product use issue). No adverse effects were reported.