Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
No other AE; Inadvertent administration of GARDASIL 9 to a 2 year old girl; This spontaneous report was received from a medical assistant, concerning a 2-year-old female (reported as girl) patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 02-Oct-2025, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (route of administration, anatomical location, lot #, and expiration date were not reported) administered as prophylaxis (Product administered to patient of inappropriate age). The medical assistant would not provide further patient information and refused to provide the lot and expiration date or any other information regarding the product. No other adverse event (AE) nor PQC were reported. Lot # is being requested and will be submitted if received.