Symptomtext
A patient was administered with an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00784366) and transmitted to Sanofi on 24-Sep-2021. This case involves a 71-year-old male patient who was administered with an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 22-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB, expiry: 30-Jun-2021, formulation: solution for injection in pre-filled syringe) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). No adverse event was reported. It was reported "Caller stated that her office started giving this seasons FLUZONE high dose (HD) vaccines but a vaccine from last season was given of the 2020-2021 FLUZONE HD and she would like to know if the patients need to be revaccinated or what the process is now? Caller states Fluzone HD was given from last season, expired dose. She asks for follow-up. She clarifies, so it can be given again immediately." 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.