Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y018297 | — |
Medical Assistant noted that there was no symptomatic events reported; medical assistant regarding T/E only GARDASIL-9 was administered.; This spontaneous report was received from medical assistant 01-Oct-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that other vaccines experienced this temperature excursion: pneumococcal 15v conj vaccine (crm197) (VAXNEUVANC), hepatitis a vaccine, inactivated (VAQTA), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), but the vaccines were no administered and the only vaccine administered was Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9). On 30-Sep-2025, the patient was vaccinated with a temperature excursion of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) prefilled syringe (lot #Y018297, expiration date: 13-Feb-2027) (dose, dose number and route of administration was not reported) for Prophylaxis (Product storage error). Operator of device was reported as a health care professional. The administered dose of the vaccine experienced a temperature excursion 46.2 degrees Fahrenheit for 30 Minutes, no previous temperature excursion reported.