Received Mar 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK368AB | OT |
reconstituted Act-HIB using a diluent different from the one supplied in the packaging (0.4% sodium chloride saline), with no reported adverse event; Initial information received on 26-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old and unknown gender patient and HIB (PRP/T) Vaccine [ACT-HIB] reconstituted using a diluent different from the one supplied in the packaging (0.4% sodium chloride saline), 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 an unknown dose of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK368AB, expiry date 31-Jan-2027 and strength not reorted) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and reconstituted using a diluent different from the one supplied in the packaging (0.4% sodium chloride saline), with no reported adverse event (product preparation error). It was reported "The employee inadvertently used sterile water that was intended for use with another vaccine. The vaccine had already been administered, and they were enquiring about safety information regarding this error." Action takenwas 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.