Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
Patient had brief episode of syncope, no additional injury.; This spontaneous report was received from a health care worker and refers to a 11-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (TDAP) . On 07-AUG-2025, the patient was vaccinate with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection (1 injection) (lot #, expiration date, route of administration, anatomical location of vaccine were not reported) in her arm for prophylaxis. On 07-AUG-2025, the patient experienced Patient had brief episode of syncope, no additional injury. In August 2025, the patient recovered from the event. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Upon internal review, the event of Syncope was determined to be medically significant. Lot # is being requested and will be submitted if reported.
Tdap