Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
She developed a painful bump on her arm at the injection site; She developed a painful bump on her arm at the injection site on 28Aug2025.she had worsening arm pain; This consumer reports that her daughter recieved her first Gardasil 9 injection in Aug2024 and did not have any problems with it. She received her second Gardasil 9, 0.5ml injection intramuscularly on 28Aug2025; This spontaneous report has been received from a consumer, regarding to a 13-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unspecified date in August 2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), , then on 28-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), both doses at a dose of 0.5 milliliter (ml), administered intramuscularly (IM), as prophylaxis (Anatomical site of injection, lot number and expiration date were not provided) (Inappropriate schedule of product administration). On 28-Aug-2025, she developed a painful bump on her arm at the injection site (Vaccination site mass, vaccination site pain). At the time of the report, the outcome of aforementioned events was not provided. The causality assessment between the events and the suspect vaccine was not provided.