Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK201AC | OT |
administration of a dose of ACT-HIB that was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who was administered with a dose of HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water rather than the diluent it came with, 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 in May 2025, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- standard, expiry date- 30-APR-2026 and lot UK201AC) once via unknown route in unknown administration site for Immunization was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event (product preparation error) (same day latency). Reportedly, Caller was stating that they submitted an online request for information on an ACT HIB vaccine. They were looking for information on if the vaccine was reconstituted with sterile water rather than saline. They received some information but were asking if there was any safety information they need to be aware of regarding the vaccine since it was administered to a patient 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.