Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
painful injection with GARDASIL 9; This spontaneous report has been received from a pharmacist, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 25-SEP-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) as prophylaxis (dose, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported). On 25-SEP-2025, the patient experienced painful injection (pain). The outcome of the event was not provvided. The causal relationship between the event and suspect vaccine was not provided. This case was determined to be non-valid due to the lack of patient's identifiers.