Received May 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK229AA | — |
inappropriate use due to ACT-HIB was reconstituted with sterile water with no AE; Initial information received on 17-Apr-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves an unknown age patient of unknown gender who received HIB (Prp/T) Vaccine [Act-Hib] which was reconstituted with sterile water instead of the correct diluent (0.4% sodium chloride) with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. In April 2026, the patient received 0.5 mL (once) dose of HIB (Prp/T) Vaccine, Powder and solvent for solution for injection of unknown strength (batch: UK229AA, expiration date: 30-Jun-2026) via unknown route in unknown administration site for immunization, which was reconstituted with sterile water instead of the correct diluent (0.4% sodium chloride) with no adverse event. [Product preparation error) [latency: Same day] It was reported that, The medical assistant stated that an extra diluent for ACT-HIB was available and there was a missing diluent for the MMRV vaccine by Merck. The medical assistant confirmed that she knows the ACT-HIB diluent is 0.4% sodium chloride (NaCl), but the MMRV by Merck diluent is sterile water. The affected patient was still unknown to the medical assistant at the time of reporting, and she stated that she would need to review patient charts from the previous week to identify the patient. Action taken: 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.
Comments: NONE