Received Feb 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
did not reconstitute the acthib and only gave th with no reported adverse evente sterile diluent; Initial information received on 12-Feb-2026 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age and unknown gender patient who received HIB (Prp/T) Vaccine [Act-Hib] which was not reconstitute and only gave sterile diluent was received with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received only the sterile diluent of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, with no reported adverse event (product preparation error) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported, "staff member did not reconstitute the ACTHIB and only gave the sterile diluent." 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.