Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
syncope; This spontaneous report was received from a Nurse via company employee and refers to a(n) 11-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-May-2025, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On 23-May-2025 (also reported as after her first dose of the GARDASIL 9 vaccine), the patient experienced syncope. At the reporting time, the outcome of syncope was unknown. The action taken with suspect vaccine was not applicable. The causal relationship between the event of syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was unknown/not reported/not provided. Upon internal review, the event of syncope was determined to be medically significant. Additional information were not expected.