Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | X025115 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | V18415MA | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | WT8413MA | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | X023113 | OT |
No additional AE; administered improperly stored GARDASIL 9; This spontaneous report was received from a reporter and refers to a 12-year-old male patient. The patient's medical history was not reported. His concurrent conditions included ADHD and autism. Concomitant therapies were not reported. On 23-Oct-2024, at a private doctor's or hospital, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot number reported as X023113, which has been verified as valid, expiration date reported and validated as 10-MAY-2026) administered by intramuscular route for prophylaxis; and with a flu vaccine. It was reported that the fridge dropped below freezing while office was closed over the weekend (Product storage error). No additional adverse events were reported. No symptoms were reported. No additional adverse event (AE) details reported. No additional AE or product quality complaint (PQC).; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-03-13 , number : , number : , number : , number : , Central date : 2025-03-10 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
ADHD; Autism