Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012508 | — |
No additional adverse event reported; HCP calling to report T/E. VFC data logger was off. HCP could not provide any temperature and time information to further evaluate GARADSIL 9. HCP did state GARDASIL 9 was administered. See T/E case# 02799358.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2025, a temperature excursion occurred. On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #Y012508; which has been verified to be valid, expiration date reported and upon internal validation establish as 01-JAN-2027 (strength, dose number, exact quantity volume, route and anatomical site of administration were not provided) administered for prophylaxis (Improper storage of product in use). It was also reported that the data logger was off so the reporter could not provide any temperature and time information to further evaluate the vaccine. No previous temperature excursion. No additional adverse event reported (No adverse event).