Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | UT8826JA | OT / LL |
administration of second dose of FLUZONE NP 11 days too early with no reported adverse event; Initial information received on 12-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old male patient who had administration of second dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]11 days too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Dec-2025, the patient received a dose of 0.5ml dose 2 of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UT8826JA, expiry date-30-Jun-2026, strength-standard via intramuscular route in the left thigh for Influenza 11 days too early with no reported adverse event (inappropriate schedule of product administration) (latency-same day). Reportedly- the patient did not have any other immunizations. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.