Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
gave a patient only the saline diluent that was not reconstituted with the actual ACTHIB vaccine with no reported adverse event; Initial information received on 05-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with only the saline diluent that was not reconstituted with the actual HIB (PRP/T) VACCINE [ACT-HIB] 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 saline diluent that was not reconstituted with the actual Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation with no reported adverse event (single component of a two-component product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. It was reported "Medical assistant wanted to make sure that the patient could be revaccinated again since the initial vaccine administered was not properly reconstituted". 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.