Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | 1965046 | — |
No adverse side effects were reported.; GARDASIL 9 that was out of range, unmonitored for an unknown amount of time at unknown temperatures. Lot number was provided, expiration date was unknown. Administered 2/3/2025; This spontaneous report was received from a physician assistant concerning to a 43-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 03-Feb-2025, the patient was vaccinated with an improper stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), pre-filled syringe, lot #1965046, expiration date no provided but upon internal verification established as 22-Jan-2026, 1 dosage form (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccine dose administered was out of range, unmonitored for an unknown amount of time at unknown temperatures (product storage error.) No adverse side effects were reported (no adverse event.) This was one of two reports received from the same reporter.