Vaccine product-related reaction

An adverse event following immunisation that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product (see CIOMS-WHO22).

In this definition immunisation means the usage (handling, prescribing and administration) of a vaccine for the purpose of immunising individuals (see CIOMS-WHO22 ), 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 interchangeably22 ).