Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | — |
patient receives a dose of ACT-HIB that was reconstituted with sterile water instead of the diluent that it came with no adverse event; Initial information received on 17-Mar-2026 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of unknown age and unknown gender who received a dose of hib (prp/t) vaccine (ACT-HIB) that was reconstituted with sterile water instead of the diluent that it came with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On an unknown date the patient received hib (prp/t) vaccine Powder and solvent for solution for injection (strength, dose, frequency, route: unknown) for immunization that was reconstituted with sterile water instead of the diluent that came with it (Product preparation error, latency: same day) (batch: 4Y0018A, expiry date: 30-Apr-2026). 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