Received Jan 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT / LA |
administration of FLUZONE NP to a patient who already received it in October with no reported adverse event; Initial information received on 21-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10-year-old male patient who had administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] who already received it in october with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jan-2026, the patient received a 0.5 ml (dose 2) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot number: U8883DA and expiry date: 30-Jun-2026 strength: standard via intramuscular route in the left deltoid who already received it On 09-OCT-2025 he also received a 0.5 ml (dose 1) of vaccine via intramuscular route in the left deltoid for influenza with no reported adverse event (extra dose administered) (latency: on same day) following the last dose of suspect. 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.