Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012508 | — |
No additional AE/no PQC.; HCP reported that improperly stored GARDASIL 9 was administered. No symptoms. Precautionary AE as temperature excursion was within the temperature excursion guidelines in the prescribing information for GARDASIL 9.; This spontaneous report has been received from a physician assistant (reported as medical assistant) (R.T), regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 23-May-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) injection, 0.5 mL, administered as prophylaxis (Lot No. Y012508 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant injection], expiration date reported and upon internal validation established as 01-Jan-2027) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency was not provided) (product storage error), after a temperature excursion of 35.04 degree Fahrenheit (F) during a time frame of 2 hours and 14 minutes. No previous temperature excursion was reported. No additional information or adverse events or PQC were provided (no adverse event).