Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 4 | — | — |
tested positive for HPV; completed a series of GARDASIL 9 in 2016 and was given another single dose in 2025; This spontaneous report was received from a nurse and refers to a 24-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2016, the patient was vaccinated with the first, second and third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (exact doses, routes of administration, anatomical locations, lot numbers and expiry dates were not reported), for prophylaxis. The patient completed the series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). On an unknown date in 2025, the patient was given another single dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiry date were not reported), for prophylaxis, after she was tested positive for human papillomavirus (HPV) (Extra dose administered). At the reporting time, the outcome of tested positive for HPV was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) regarding the event was not reported but assessed as not applicable. The causal relationship between the event of tested positive for HPV and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot# is being requested and will be submitted if received.