Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | Z011449 | OT / LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
Caller reported AE on behalf of a patient who received GARDASIL 9 vaccines that were administered at shorter than recommended intervals. Caller reported that patient was administered first dose on 07/16/2025, second dose on 08/19/2025, and third dose; vaginal bleeding following third; This spontaneous report was received from a nurse and refers to a 44-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-Jul-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z011449, expiration date: 26-Aug-2027) 0.5 mL (0.5ml/dose), administered by Intramuscular route in Left Deltoid; On 19-Aug-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (anatomical location, administration route, lot # and expiration date were not reported) and finally on 16-Oct-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (anatomical location, administration route, lot # and expiration date were not reported); all the doses administered as prophylaxis. The reporting nurse stated that the patient received 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) that were administered at shorter than recommended intervals. It was also confirmed that the patient called to the office on 17-Oct-2025 and reported experiencing vaginal bleeding following third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (on an unspecified date in October 2025). The "agent" triaged the patient and informed the patient that the level of vaginal bleeding was not considered severe At the reporting time, the patient had not recovered from vaginal bleeding following third dose. The causal relationship between the event of vaginal bleeding following third dose and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received.