Reporte zur Charge UT700BA

Symptomtext

influenza vaccine expired in June was administered to a baby with no reported adverse event; Initial information received on 14-Sep-2021 regarding an unsolicited valid non-serious case from physician and consumer/ non healthcare professional via Media Information (under reference 00767922). This case involves a 9 months old male patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Sep-2021, the patient received a 0.5 mL dose of suspect FLUZONE QIV (total, lot UT700BA and expiration date: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported "HCP (health care professional) states influenza vaccine expired in June was administered to a baby and would like recommendations on what to do." At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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.