Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK092AB | OT |
expired ACTHIB was given with no reported adverse event; Initial information received on 23-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant patient with unknown gender who was administered to expired HIB (PRP/T) Vaccine [ACT-HIB] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jun-2025, the patient received expired 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK092AB, strength standard, frequency once and expiry date not reported) via unknown route in unknown administration site for Immunization (expired product administered) (latency same day). Reportedly, they wanted to know if it has to be re-administered. Action taken was 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.