Symptomtext
FLUZONE HD vaccine from last year, which expired with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00829588) and transmitted to Sanofi on 27-Oct-2021 in a specific country. This case is linked to case 2021SA359222 (CLUSTER). This case involves an 85-year-old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 26-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe, lot UJ515AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used. (latency: same day). It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is." At time of reporting, no reported 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.