Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | — |
early administration of the second FLUZONE NP dose, gave a flu shot to a child who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient who received early administration of the second INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] dose, gave a flu shot to a child who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark 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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination ( Immunization). On 15-Sep-2025 Patient received Dose 1 of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE, Suspension for injection (dose, strength, route, lot, expiry, administration site: Unknown) for influenza. On 03-Oct-2025, the patient received a Dose 2, 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UT8836NA and expiry 30-Jun-2026) (strength: unknown), early administration of the second fluzone np dose, gave who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark with no reported adverse event (inappropriate schedule of product administration) (latency same day) via intramuscular route in the right thigh for influenza. 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.
PREVNAR; VAXELIS; ROTATEQ