Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | X022735 | — |
No additional AE; Caller reported AE on behalf of a pediatric patient who was inadvertently administered GARDASIL 9 on 10/22/2025.; This spontaneous report has been received from an other health professional, regarding a 6-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 22-OCT-2025, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), at a dose of 0.5 milliliter (ml), as prophylaxis (lot number X022735, expiration date: 12-Apr-2026) (route of administration and anatomical site of injection was not provided). No additional adverse events were reported in the patient.