Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
inappropriate use (unknown intention) due to the reconstitution of ACTHIB with sterile water and subsequent administration to a patient with no reported adverse event; Initial information received on 12-Dec-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who experienced inappropriate use (unknown intention) due to the reconstitution of Hib (Prp/T) Vaccine [Act-Hib] with sterile water 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 0.5mL dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (once), Strength Standard, lot number and expiry date not reported via unknown route in unknown administration site for immunisation which was reconstituted with sterile water and subsequent administration to a patient 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. 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.