Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
pt received wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%) with no reported adverse event; Initial information received on 01-Aug-2025 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 HIB (PRP/T) vaccine [ACT-HIB] with wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Aug-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine with wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%),Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for routine vaccination (Immunisation) with no reported adverse event (product preparation error) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.