Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK201AC | OT |
vaccine mixed with sterile water instead of the saline diluent with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was mixed with sterile water instead of the saline diluent 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 HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 30-Apr-2026 and lot UK201AC) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization) was mixed with sterile water instead of the saline diluent with no reported adverse event (product preparation error) (latency- same day). 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.