Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; Bump on the head; This spontaneous report was received from a Nurse referring to a 10-year-old male patient. The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered by Health Professional as prophylaxis (dose, route of administration, lot #, and expiration date were not reported). On an unknown date, the patient had syncope and passed out (syncope, loss of consciousness). He fell and hit his head and went to the emergency department (ER) (head injury). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Upon internal review, the events of syncope and loss of consciousness were determined to be medically significant. Lot # is being requested and will be submitted if received.
Comments: unknown