Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
fainted; This spontaneous report was received from a Nurse via company representative and refers to an Adolescent male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (recently), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced fainted after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) at the office. At the reporting time, the outcome of fainted was unknown. The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown (They were not certain that it was associated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) and the patient had not eaten that morning). Upon internal review, the event(s) of fainted was determined to be medically significant.