Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8863DA | OT |
pediatric patient was given FLUZONE too early. Patient is 5 months old and received the FLUZONE vaccine with no AE; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case (along with live follow-up processed together with csd dated: 21-Oct-2025) received from a other health professional. This case involves a 5 months old pediatric male patient who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] 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 20-Oct-2025, the pediatric patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8863DA, expiry date:30-Jun-2026, strength not reported via unknown route in unknown administration site for influenza too early no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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.