Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8883CA | IM |
administering fluzone np to a patient below 6 months old with no reported adverse event; Initial information received on 26-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 month old male patient who experienced administering fluzone np to a patient below 6 months old with no reported adverse event after receiving influenza usp trival a-b subvirion no preservative vaccine (FLUZONE NP). The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included vaxelis (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), prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), and rotarix (Rotavirus vaccine live oral 1v). On 24-Mar-2026, the patient of 1 month old received a 0.5 mL once dose of influenza usp trival a-b subvirion no preservative vaccine suspension for injection (batch: U8883CA, expiry: 30-Jun-2026) (strength: Standard) via intramuscular route in left vastus lateralis for influenza (immunisation) with no adverse event (inappropriate age at vaccine administration) (Latency: same day). It was reported, "Public Health Nurse asked what kind of adverse events can be expected when FLUZONE NP was administered too early. The patient is currently 2 months old and he was given with it accidentally. The vaccine is indicated for 6 months and older. The patient had a doctor visit today, 26Mar2026, for a routine checkup. They brought the immunization record and that's when the physician noticed the administration of FLUZONE NP. " Action taken: drug was withdrawn on 24-Mar-2026. 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.
Vaxelis; Prevnar 20; Rotarix