Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y015599 | OT / RA |
Then she received her second dose (out of the 2 dose series) on 04AUG2025 and received her dose in her Right arm intramuscularly and swelling started at the injection site and it became an abscess.; First dose on 20May2024, second dose on 04Aug2025; A medical assistant called and reported an AE where a 12 year old healthy female received their first dose of GARDASIL 9 on 20MAY2024. The consumer experienced swelling at the injection site at that time.; This spontaneous report was received from a Physician Assistant and refers to a currently 12-year-old female patient. The patient had no medical history, concurrent conditions, concomitant therapies, no drug reactions or allergies. It was stated that she was healthy. On 20-May-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (lot #, expiration date, strength, route of administration, anatomical location not provided) as disease prevention. On an unspecified date in 2024 (reported as "at that time") after first dose, the patient experienced swelling at the injection site. On 04-Aug-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y015599, expiration date: 10-Feb-2027), administered by Intramuscular route in the Right Arm as prophylaxis (inappropriate schedule of vaccine administration). On the same date after second vaccination, swelling started at the injection site and it became an abscess. As treatment for this event, she received clindamycin, and even though she was not hospitalized, the patient needed surgery and incision and drainage (I&D) procedure. At the reporting time, the patient was recovering from vaccination site abscess, while the outcome of vaccination site swelling was unknown. The causal relationship between both events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported.