Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK208AA | OT / RL |
the Medical Assistant did not mix the diluent with the vaccine itself, so the patient was only administered with the ACTHIB diluent with no reported adverse event; Initial information received on 01-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 months old female patient and it was reported the medical assistant did not mix the diluent with the HIB (PRP/T) VACCINE [ACT-HIB] itself, so the patient was only administered with 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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) for Immunisation. On 26-Nov-2025, the patient received a dose 3 of 0.6 ml once of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (lot: UK208AA; expiry date: 30-Apr-2026) via intramuscular route in the right thigh for Immunisation and the medical assistant did not mix the diluent with the vaccine itself, so the patient was only administered with the acthib diluent 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)