Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK230AA | OT / LL |
mixed up the ACTHIB, instead of using the sodium chloride diluent that comes in the box, they actually used the sterile water that comes for chicken pox and MMR with no reported adverse event; mixed up the ACTHIB, instead of using the sodium chloride diluent that comes in the box, they actually used the sterile water that comes for chicken pox and MMR with no AE; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was administered to mixed up Hib (Prp/T) Vaccine [Act-Hib], as instead of using the sodium chloride diluent that comes in the box, they actually used the sterile water that comes for chicken pox and mmr 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, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 30-Sep-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK230AA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation) and mixed up the acthib, instead of using the sodium chloride diluent that comes in the box, they actually used the sterile water that comes for chicken pox and mmr with no reported adverse event (product preparation error), (poor quality product administered) (latency same day). Reportedly, nursing supervisor wanted to see if the dose was viable or they need to revaccinate the child. 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.
Dtap