Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
My daughter was given Gardasil and developed pain at the site of the injection 1 day later. Please let me know if there's other information needed; This spontaneous report was received from a company representative and refers to a female patient of unknown age. The patient's medical history, current conditions, and concomitant therapies was not reported. On an unknown date, the patient was vaccinated Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, anatomical route of administration, lot # and expiration date were not reported) as prophylaxis. The reporter stated that the patient developed pain at the site of the injection 1 day later (exact dates not provided) (vaccination site pain). The outcome of the event vaccination site pain was not reported. The causal relationship between vaccination site pain with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not reported. Lot number is being requested and will be submitted if received.