Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
calling on behalf of Medical Assistant with a report of an adverse event regarding GARDASIL 9. FBE reporting that the Medical Assistant stated: "A patient of our practice was inadvertently administered a dose of GARDASIL 9 when they were 2 month; No additional AE; This spontaneous report has been received from a certified medical assistant (C.M.A.) via company representative and refers to a 2-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On an unknown date, at the age of 2 months old, the patient was inadvertently administered a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 ml (lot#, expiration date, route of administration, anatomical location were not reported), for prophylaxis (Product administered to a patient of inappropriate age). At the reporting time, the patient was 11 years old and the reporter was inquiring if the patient would be eligible for vaccination with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as they were within the recommended age. The reporter confirmed they did not receive any reports of the patient having any medical concerns or symptoms at the time they were administered the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) inadvertently. No additional adverse event was reported. Lot# is being requested and will be submitted if received.