Reporte zur Charge UJ328AB

Symptomtext

expired dose of ACT HIB had be administered with no reported adverse event; 68 year old patient administred ACT-HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and pharmacist via Global Medical Information (Reference number- 00684494) and transmitted to Sanofi on 15-Jul-2021. This case involved a 68 year old male patient who administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 15-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ328AB and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age and expired product administered) It was reported that, "the caller stated that an expired dose of ACT HIB had be administered. What are our recommendations"? This case was an actual medication error (expired vaccine used and Inappropriate age at vaccine administration) (latency same day) At the time of reporting, no adverse event 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.