Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; This spontaneous report was received from a Consumer or other non health professional and refers to an Adolescent female patient. 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, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (unconfirmed which one) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient had tried to get up right after receiving it and fainted and went down. The outcome of the events was not reported. The causality between the events and suspect vaccine was not provided. Upon internal review, the event of syncope was considered to be medically significant. Lot# is being requested and will be submitted if received.