Received Apr 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK331AA | IM |
Incorrect diluent used to reconstitute vaccine. Sterile water was used instead of Nacl with no reported adverse event; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from a Nurse (Health Care Professional). This case involves a 147-year-old male patient who had ACTHIB with incorrect diluent used to reconstitute vaccine, sterile water was used instead of Nacl with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. In an unknown date, the patient received a 0.5 mL of ACTHIB [ACT-HIB] (Powder and solvent for solution for injection) (batch: UK331AA, expiry: Jul-2026) (strength: unknown) via intramuscular route in an unknown administration site for Immunization (Immunisation). Incorrect diluent used to reconstitute vaccine. Sterile water was used instead of Nacl with no reported adverse event (Product preparation error, Onset: unknown, Latency: unknown). Parents of patient have been informed of need to repeat vaccine. 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