Received Nov 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
a patient fainted; This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. In November 2025 (reported as last week), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), Suspension for injection (indication, expiration date, and lot # were not reported). The patient's parents did not want to wait the recommended 15 minutes and the patient fainted in the hallway. At the reporting time, the outcome of event was unknown. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Upon internal review, the event(s) of a faint was determined to be medically significant.