Reporte zur Charge U71255AA

Symptomtext

VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388). Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable. No further information is expected given that there were no adverse events following Vaxelis administration post-excursion. For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.