Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015179 | OT / RA |
No additional AE; TE for GARDASIL 9 with multiple excursion that occurred over 09/25/2025 through 10/31/2025 and was inadvertently administered.; device or device component malfunction checked; This spontaneous report was received from nurse and referred to a 10-year-old female patient. The patient's concomitant therapies included influenza vaccine (reported as flu vaccine), meningococcal vaccine and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (reported as TDAP vaccine). Her pertinent medical history, concurrent conditions, previous drugs reactions and allergies were not reported. It was reported that over 02-Sep-2025 through 31-Oct-2025, multiple current excursions occurred with accumulative max temperature of 8.9 degrees Celsius (C) for accumulative total of 44 minutes, and on 10-Oct-2025, the patient was vaccinated with an improperly stored dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) suspension for injection, administered intramuscular in the right deltoid as prophylaxis (Lot No. Y015179 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date not reported, but upon internal validation established as 28-Jan-2027) (strength, dose number, exact dose quantity volume and vaccination scheme frequency were not provided) (product storage error). It was stated that device or device component malfunction occurred (device malfunction). No adverse event was reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-12-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-12-16 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
FLU VACCINE; MENINGOCOCCAL VACCINE; TDAP VACCINE