Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013565 | — |
no adverse reactions were experienced after the administered dose; HBP (in charge of vaccine storage) called to report TE occurring on 8/16/2025 and 8/17/2025 for GARDASIL-9 and VAQTA that were administered after TE on 8/18/2025. (one patient was administered VAQTA & GARDASIL-9; and 3 patients were administered GARD; This spontaneous report was received from an Administrator / Supervisor (Office Manager) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, 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 9) Suspension for injection (reported as injection) (valid lot #Y013565, expiration date: 01-Feb-2027) 0.5 mL administered for prophylaxis. Administered dose of suspect vaccine was exposed to the temperature excursion on 16-AUG-2025 and 17-AUG-2025: 1.5 Celsius degrees (C) for 2 hours, 24 minutes, 0 seconds and 0.9 C for 5 hours, 14 minutes, 0 seconds (product storage error, onset date: 18-Aug-2025). Previous temperature excursion was reported as on 08-JUL-2025: 8.3 C for 0 hours, 44 minutes, 0 seconds. There was no additional adverse event reported (no adverse event). This is one of several reports received from the same reporter.