Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013565 | — |
No additional AE; GARDASIL-9 was administered after TE on 8/18/2025; 3 patients were administered GARDASIL-9.; This spontaneous report was received from an office manager, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL) SYRINGE 0.5 mL (involved lot # Y013565 has been verified to be valid, expiration date: 01-Feb-2027); administered for prophylaxis (route, and site of administration were not provided). Temperature excursions were (1.5 C) Celsius (C) and time frame was for 2 hours, 24 minutes, 0 seconds; (0.9 C) for 5 hours, 14 minutes, 0 seconds. There was a previous temperature excursion 7/8: (8.3 C) for 0 hours, 44 minutes, o seconds. No report of adverse effect nor product quality complaint involved. This is one of four reports from the same reporter.