Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015179 | — |
No symptoms reported; HCP reported administration of GARDASIL 9 that experienced two temperature excursions; This spontaneous report was received from a Registered medical assistant 15-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Jul-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y015179, expiration date: 28-Jan-2027) prefilled syringe, dose: 0.5 mL (dose number, route and anatomical location was not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion of 47.3 Fahrenheit for 50 minutes and 24 seconds. Previous excursion was not reported as 47.5 Fahrenheit for 36 minutes and 51 seconds. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source.