Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y015179 | OT / RA |
No additional AE; Device or device component malfunction; GARDASIL 9 with multiple excursion that occurred over 09/02/2025 through 10/31/2025 and were inadvertently administered; This Spontaneous report was received from a Nurse and referred to an 11 -year-old Female patient. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. The patient's concomitant medication included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) and meningococcal vaccine. Over 02-Sep-2025 through 31-Oct-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) underwent multiple excursions with a cumulative max temp of 8.9 C for a cumulative total of 44 minutes. On an unknown date in 2025, the patient was vaccinated with the improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Lot Number: Y015179, expiration date: 28-Jan-2027), first dose, via Intramuscular (Anatomical Site: Right Deltoid) (dose was not provided) as Prophylaxis (Product storage error). In addition, it was reported that the event was attributable to the device or device component malfunction (Device malfunction). No adverse event reported. Vaccines were moved to backup location in early November 2025. This is one of several reports received from the same reporter.
TDAP; meningococcal