Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK169AC | IM |
administering an expired dose of ACTHIB, with no reported adverse event; Initial information received on 16-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 months old female patient who experienced administering an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB], with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (DTAP VACCINE) and varicella zoster vaccine (VARICELLA VACCINE). On 07-Apr-2026, the patient received a 0.5 ml once dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] powder and solvent for solution for injection (batch: UK169AC, expiry: 28-Feb-2026) (strength: standard) via intramuscular route in left ventrogluteal site for immunization. The nurse manager called saying that they gave a patient an expired HIB vaccine. She requested documentation so they could update the patient's chart. She confirmed that vaccine was given on 07-Apr-2026, and it expired back in February with no reported adverse event (Expired product administered and latency: same day). Action taken: Unknown 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
DTaP vaccine; Varicella vaccine