EMA: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases

Vaccine pharmacovigilance has been defined by the CIOMS/WHO Working Group on Vaccine Pharmacovigilance as the science and activities related to the detection, assessment, understanding and communication of adverse events following immunisation and other vaccine-or immunisation-related issues, and to the prevention of untoward effects of the vaccine or immunisation.