Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | 1957404 | — |
No adverse event; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administered to a patient on 03/11/2025. The GARDASIL 9 experienced two separate TE's before being administered.; This spontaneous report was received from a Consumer or other non health professional and refers to an 18-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #1957404, which was confirmed to be valid, expiration date: 05-Oct-2025 (dose, units, and route of administration were not reported) for prophylaxis. It was reported that the vaccine experienced two separate temperature excursions (TE's) before being administered (Product storage error). Temperature on 29-JAN-2025 was 35.8 F, and on 30-JAN-2025, it was 35.6 F for the time frame of 15 minutes and 10 minutes. No additional details were provided. There was no additional AE/PQC reported (No adverse event).