Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
Body Aches; Swelling; Chills; Night sweats; Arm redness; Arm Warmth; This spontaneous report was received from a Consumer or other non health professional via company representative and refers to him/herself, a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUL-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 1 dosage form, administered as prophylaxis (exact dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2025, the patient experienced body aches (Pain), chills, night sweats, arm redness and warmth (vaccination site erythema, vaccination site warmth) and swelling. At the reporting time, the outcome of the events was not provided. The causal relationship between all the reported events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported.