Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
administered the ACT-HIB with sterile water instead of the saline solution that it comes with, with no reported adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional, processed together with live Follow up with same CSD. This case involves an unknown age and unknown gender patient who was administered the HIB (PRP/T) VACCINE [ACT-HIB] with sterile water instead of the saline solution that it comes with, 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 a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (Lot number , strength, dose and expiry not reported) via unknown route in unknown administration site as immunization which was administered with sterile water instead of the saline solution that it comes with, with no reported adverse event (product preparation error) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "ActHIB must be reconstituted only with 0.4% sodium chloride ActHIB diluent. Any dose of ActHIB reconstituted with a diluent other than specific ActHIB diluent should not be counted as valid and must be repeated. Non-live vaccines, such as ActHIB, should be repeated as soon as possible." Action taken: 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.