Vaccine quality defect-related reaction

An adverse event following immunisation that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer (see CIOMS-WHO23).

In this definition immunisation means the usage (handling, prescribing and administration) of a vaccine for the purpose of immunising individuals (see CIOMS-WHO23 ), which in the EU is preferably referred to as vaccination (in the report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance the terms immunisation and vaccination are used interchangeably23 ).

For the purpose of this definition, a vaccine quality defect is defined as any deviation of the vaccine product as manufactured from its set quality specifications (see CIOMS-WHO23 ).