Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | X025115 | OT |
No additional AE; Fridge dropped below freezing over the weekend while office was closed; This spontaneous report has been received from a healthcare professional regarding a 11-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection, administered intramuscularly as prophylaxis (lot number reported as X025115, which has been verified as valid, expiration date reported and validated as 19-MAY-2026). It was reported that the fridge dropped below freezing over the weekend while office was closed (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-03-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 02743778 RD , Central date : 2025-03-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :