Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT / LL |
4- month-old patient received Fluzone NP in error with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old and unknown gender patient who received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] in error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel), Pneumococcal vaccine conj 7v (CRM197) (Prevnar); and Rotavirus vaccine for Immunisation. On an unknown date, 4- month-old patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Strength = standard) dose 0. 5ml 1x(once) Suspension for injection (batch and expiry date unknown) via intramuscular route in the left thigh for Immunization, in error with no reported adverse event (wrong product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken- 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.
Pentacel; Prevnar; Rotavirus vaccine