Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
FBE reports that the patient fainted after GARDASIL 9 administration; This Spontaneous report was received from consumer or other non-healthcare professional via company representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, past and concomitant medications were not reported. On an unknown date, patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 0.5 mL (reported as 0.5 ml/ series) administered for prophylaxis (strength, lot number, expiration date, route and anatomical site of administration were not provided). On an unknown date, the patient fainted (syncope) after the vaccine administration. At the reporting time, the outcome of the event was not provided. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported. Upon internal review, the event of fainted (syncope) was considered to be a medically important condition.