Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UJ995AA | OT |
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient with inappropriate use due to administration of an expired vaccine (HIB (PRP/T) VACCINE [ACT-HIB]) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection (strength -standard) lot UJ995AA expiry date-28-Feb-2025 via intramuscular route in right leg for Immunization, inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (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.