Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
female patient was administered 2 doses of GARDASIL in her teens/ indicates that the patient *may* be vaccinated soon with a 3rd dose; Inbound transfer of an HCP calling. HCP reported that his 42 year old female patient was administered 2 doses of GARDASIL in her teens and has now tested positive for HPV. HCP refused to offer further information or to be contacted as he st; This spontaneous report was received from a physician and refers to a(n) 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates (when the patient was a teenager), the patient was vaccinated with the first and the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for HPV prevention. On an unknown exact day in April 2025 (estimated date, reported as: now), the patient experienced human papilloma virus test positive. It was indicated that the patient may be vaccinated soon with the third dose of vaccine (inappropriate schedule of vaccine administered). At the reporting time, the patient not recovered from the event human papilloma virus test positive. The causal relationship between the event of human papilloma virus test positive and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown/not reported/not provided.