Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8861MA | OT / RL |
a 2 month old patient received a dose of FLUZONE NP with no reported adverse event; Initial information received on 09-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who received a dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] 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 Rotavirus vaccine live reassort oral 5v (Rotateq); Diphtheria vaccine toxoid, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Vaxelis); Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20); and Nirsevimab alip (Beyfortus) all for Immunisation. On 09-Dec-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection with standard strength (expiry date- 30-JUN-2026 and lot UT8861MA) via intramuscular route in the right thigh for Influenza (Influenza immunisation) with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). It was reported that, "Treatment: None." 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.
Rotateq; Vaxelis; Prevnar 20; Beyfortus