Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
the HCP believes she is in the "initial stages of vulvar cancer; the patient has had problems; This spontaneous report was received from a physician via company representative and refers to a 34-year-old female patient. The patient's medical history included vulvectomy, sexual debut in 2005, and had a child in 2008. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unspecified date in 2009, the patient completed the vaccine series with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, dose, frequency, lot #, and expiration date were not reported) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot #, and expiration date were not reported) for prophylaxis (reporter stated she believed, however was unable to confirm which vaccine the patient received). Since 2016, the patient had had problems. No additional details were provided regarding those problems. The patient was seen on 13-FEB-2025, the healthcare provided (HCP) believed she was in the "initial stages of vulvar cancer." No additional details provided. At the reporting time, the outcome of the events was unknown. The causal relationship between the events, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown. Lot # is being requested and will be submitted if received. Upon internal review, the event of vulvar cancer was determined to be medically significant.
Medical History/Concurrent Conditions: Pregnancy; Vulvectomy