Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK016AC | OT / LA |
administration of an expired product to a patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 2 years,8 months old female patient to whom administered expired 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 a 0.5 ml dose of suspect Hib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot UK016AC , unknown strength, expiry date:28-feb-2025, via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (latency: same day). 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.