Received Mar 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8878KA | IM / LL |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
physician ordered Hep B but the nurse accidentally administered FLUZONE NP instead with no adverse event; pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to the accidental administration of FLUZONE NP to a four-week-old patient with no reported adverse event; Initial information received on 10-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP), processed together with live follow up of same CSD. This case involves a 1-month-old female patient for whom physician ordered hepatitis B vaccine but the nurse accidentally administered influenza USP trival, A-B subvirion no preservative vaccine [fluzone] instead and was pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to the accidental administration of fluzone to a four-week-old patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On 10-Mar-2026, the patient of 4 weeks old accidentally received a dose 1 with dosage 0.5 milliliter (mL) once dose of influenza USP trival, A-B subvirion no preservative vaccine suspension for injection (batch: UT8878KA, expiry: 30-Jun-2026) (strength: standard) via intramuscular route in left thigh for immunization instead of hepatitis B vaccine (batch and expiry: unknown) (strength: unknown) with no adverse event (wrong product administered and product administered to patient of inappropriate age) (Latency: same day). Information regarding batch number and expiration 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.