Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
sterile water was used instead of saline to dilute ACT-HIB with no reported adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient as sterile water was used instead of saline to dilute 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 sterile water was used instead of saline to dilute HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (product preparation error) (same day latency). Information on batch number and expiry 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.