Received Aug 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
one daughter developed a "knot" on her breast.; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) caused a removal of cervix (Hysterectomy) for 2 daughters (captured in cases # 2320735 and 2320738) and one daughter developed a "knot" on her breast (Breast mass). At the reporting time, the outcome of breast mass was not provided. The reporter considered the event of breast mass to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). This is one of three reports from the same reporter.