Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK111AA | OT |
stated that a patient was given ACTHIB, however the diluent that was given was a diluent that they use for MMR and Varicella vaccines and not the one for ACTHIB with no reported adverse event; Initial information received on 15-May-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 with HIB (PRP/T) vaccine [ACT-HIB] however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-May-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK111AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event (product preparation error) (latency-same day). Reportedly- Patient age '<'1 year enter as 2m, 4m, etc, the ACTHIB wasn't reconstituted using its accompanying diluent. 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.