Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012864 | — |
No symptoms. No additional AE; HCP reported improperly stored administered GARDASIL 9.; This spontaneous report was received from a medical assistant concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 21-Apr-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, lot #Y012864 has been verified to be a valid batch/lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation established as 29-May-2026, 0.5 mL (dosage regimen, anatomical location and route of administration was not provided) administered as prophylaxis (product storage error). At the time of vaccination, the vaccine administered underwent a temperature excursion at 8.5 degrees Celsius (C) for 0 hours 4 minutes 0 seconds, with a previous temperature excursion at 1.5 C for 90 hours 35 minutes 0 seconds There were no symptoms nor additional adverse events (AE) (no adverse event.) This was one of two reports received from the same reporter.