Received Jan 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
Patient fainted after receiving her first dose of GARDASIL 9 on 02JAN2026; This Spontaneous report was received from a physician via Company representative concerning a 15 -year-old female patient. The patient's medical history, past medications, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 02-Jan-2026, she was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (batch/lot#, expiration date, anatomical location and route of administration were not reported) administered as prophylaxis. On that day, after receiving the vaccine, the patient fainted (syncope.) The outcome of the event was not provided. The causal relationship between syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Upon internal review, the event syncope was considered to be other medically important condition. Batch/lot# is being requested and will be submitted if received.