Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK010AA | OT / LL |
administration of an expired product (with no reported adverse event); Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who was administrated with expired product 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 04-Mar-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025) via intramuscular route in the left thigh for immunisation and administration of an expired product (with no reported adverse event) (expired product administered) (latency same day) Action taken was not applicable. Reportedly, Nurse Manager called asking if the given dose for patient was valid or if another dose must be given after realizing that the vaccine has expired last 28-Feb-2025. 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.