Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK201AC | OT |
Wrong diluent was used to mix the vaccine (hib) live vaccine diluent used with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient (6.35 cm and 10.45 kg) who received Hib (Prp/T) Vaccine [Act-HIB] in which wrong diluent was used to mix with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2025, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection, lot UK201AC, expiry date:30-Apr-2026 via intramuscular route in unknown administration site for Immunization which was mixed with wrong diluent to mix to used with no reported adverse event (product preparation error) (latency: same day). Reportedly, a patient received the HIB vaccine, but one of the diluents was missing. Office manager reported that they are trying to narrowit down to which patient received the vaccine without the diluent. Sales rep assumes that it was the ACTHIB. Vaccine will be readministered at 18-month wellness appointment. 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. Additional information was received on 08-Sep-2025 received from other health professional: case was upgraded from non valid to valid case: patient demographics, batch number, expiry date has been added and event verbatim and LLT has been updated, text amended accordingly.