Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y015180 | — |
Confirmed no symptomatic adverse events at this time; one dose of GARDASIL-9 in the summer of 2024 and another dose on 27- JUN-2025.; This spontaneous report was received from a nurse concerning a 35-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. The patient received 3 doses of HPV vaccine VLP rL1 4v (yeast) (GARDASIL) as a teenager. On approximately 20-Jun-2024 (reported as "in the summer of 2024"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (route of administration, anatomical location, bath/lot # and expiration date were not reported). On 27-Jun-2025, the patient was vaccinated by a health professional with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, batch/lot #Y015180 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation confirmed as 28-Jan-2027, 0.5 mL (anatomical location and route of administration were not reported) (inappropriate schedule of product administration). Both vaccine doses were administered a prophylaxis Confirmed no symptomatic adverse events at this time (no adverse event.) Batch/lot# is being requested and will be submitted if received.