Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y007197 | — |
syncope; This spontaneous report was received from a Certified Medical Assistant and refers to a 17-year-old male patient. The patient had no pertinent medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported). On 08-MAY-2025, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), pre-filled syringe, 0.5ml, intramuscularly, lot #Y007197 expiring on 18-AUG-2026, for prophylaxis. On 08-May-2025, the patient experienced syncope. The patient sought medical attention. As treatment, the patient laid down and the syncope resolved within 15 minutes. The reporter states this was a brand new box of Human Papillomavirus 9-valent Vaccine, Recombinant Injection, (GARDASIL 9) and so far they have given 3 doses out of this box and have had the same issue with each patient. The reporter said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. The reporter considered the event of syncope to be related to Human Papillomavirus 9-valent Vaccine, Recombinant. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. Upon internal review, the event of syncope was determined to be medically significant. This is one of several reports received from the same reporter.