Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
a patient fainted during the 15 minute observation period after receiving a GARDASIL 9 dose.; This spontaneous report was received from a physician and refers to a 14-year-old male patient. The patient's concurrent conditions included dehydration and was fasting. His medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose number, route of administration, site of administration, lot #, and expiration date were not provided) given as prophylaxis. Later, during the 15-minute observation period, the patient fainted (Syncope). The patient went to vaccination dehydrated and fasting. At the reporting time, the outcome of the event, as well as, if patient sought medical attention, if treatment was given for the adverse event or if laboratory diagnostics or studies were performed, were unknown. The causal relationship between the event of syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was not reported. Upon internal review, the event of syncope was determined to be medically significant. Batch/Lot number is being requested and will be submitted if received.
Dehydration; Fasting