Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
The caller stated that yesterday in the shower, her son noticed a "nodule" on his arm. The nodule is on the same arm (deltoid area) where the vaccine was administered; he has pain/irritation if the nodule is pressed on; he has pain/irritation if the nodule is pressed on; This spontaneous report was received from a consumer regarding a 13-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On approximately 21-APR-2025 (also reported as about 3 weeks ago), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered on the deltoid area (unspecified) for prophylaxis (strength, dose, vaccination scheme, route of administration, lot number, and expiration date were not reported). On 11-MAY-2025, the patient noticed a "nodule" on his arm. The nodule was on the same arm where the vaccine was administered (Vaccination site nodule). The patient also had pain/irritation if the nodule was pressed on (Vaccination site pain, Vaccination site irritation). The outcome of the events was unknown. The reporter considered the events to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).