Adverse reaction – any unintended and harmful reaction to a medicinal product; any unintended and harmful reaction to a vaccine, tuberculin, if it is caused or accelerated by the active component (one of the other components) or is associated with irregularities arising in the manufacturing process of the vaccine, tuberculin, including the administration device provided by the manufacturer;
Regulatory references: paragraph 2 of Chapter I of the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996).
