Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
fainted; This spontaneous report was received from a physician via a company employee and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (exact dose, expiration date, lot #, route of administration, and anatomical location were not reported) for prophylaxis. On that day, after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), the patient fainted. Once the patient was responsive again, she was assessed and allowed to leave with her father. The patient returned to school after their doctor's visit and proceeded to participate in normal activities during and after school, including sports, with no issue. No further issues were reported about this patient. At the reporting time, the outcome of the event was not reported. The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was not provided. Upon internal review, the events of fainted was determined to be medically significant.