Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK227AC | OT / RA |
administration of incorrectly reconstituted ACTHIB with sterile water instead of the ACTHIB diluent, with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an unknown age and unknown gender patient who was administered incorrectly reconstituted HIB (PRP/T) vaccine [ACT-HIB] with sterile water instead of the acthib diluent, 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) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) both for prophylactic vaccination (Immunisation). On 01-Jul-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine that was incorrectly reconstituted with sterile water instead of the acthib diluent (formulation: Powder and solvent for solution for injection) (lot UK227AC and expiry date: 30-Jun-2026) (strength: standard and frequency: once) via intramuscular route in the right deltoid for immunisation with no reported adverse event (product preparation error) (Latency: same day). 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; Prevnar 20