Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK306AA | IM |
ACT-HIB vaccine, which was reconstituted with a sterile solution and not with the diluent it came with, was administered to a patient, with no reported adverse event; Initial information received on 04-May-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15-month-old patient of unknown gender who was administered with haemophilus type B (HIB) vaccine (ACT-HIB) which was reconstituted with a sterile solution and not with the diluent it came with, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 23-Apr-2026, the patient received dose 4 of suspect haemophilus type B (HIB) vaccine (ACT-HIB) powder and solvent for solution for injection (strength: unknown) as 4X , btach:UK306AA, expiry date not reported via intramuscular route in the leg (not otherwise specified) for immunization, which was reconstituted with a sterile solution and not with the diluent it came with, no reported adverse event (Product preparation issue, latency: same day). 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