Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y007197 | — |
No additional AE; Customer called to report TE. GARDASIL9 was administered to 2 patients. 2 separate AE cases were filled. AE case # 02873617 and AE case# 02873597. No additional AE/no PQC. ? Names of vaccines involved (including lot/exp) GARDASIL9 Y007197 08/1; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-Aug-2025, the patient was vaccinated with improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), formulation: injection, lot #Y007197, expiration date: 18-Aug-2026, exact dose 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, administered dose of vaccine was exposed to the temperature excursion of 71.11 degrees Fahrenheit (F) for 5 minutes. The previous temperature excursion of 52.16 F for 1 hour (product storage error). No additional adverse event reported (no adverse event). This is one of two reports received from the same reporter.