Tools and methods
To develop internationally harmonized tools and methods to support country vaccine safety activities
Vaccines are among the safest and most effective medical interventions. Yet, on very rare occasions, they may cause severe adverse events. Such events are extremely uncommon and may occur anywhere in the world.
It is important that vaccine safety monitoring methods, investigation procedures and public health responses are harmonized. Only then can safety data from one situation be used to help prevent problems in another.
Tools and methods for vaccine safety are rapidly evolving thanks to modern information technologies. WHO works with leading global experts with a range of expertise and from different backgrounds to develop standard procedures and methods.
International standardization of data records will facilitate the exchange of information and the global identification of vaccine safety signals.
Standard procedures and methodologies
AEFI core variables
AEFI reporting form
Aide-memoire on AEFI investigation
Revised aide-memoire on assessing causality after AEFI
- Causality assessment of an adverse event following immunization - User manual for the revised WHO AEFI causality assessment classification
- Information sheets on observed rates of vaccine reactions
- Safety of mass immunization campaigns - 2002 (pdf, 378kb)
- Safety of immunization during pregnancy - a review of the evidence by the GACVS
- Post-marketing surveillance of rotavirus vaccine safety
National and International institutions
Definition and Application of Terms for Vaccine Pharmacovigilance: Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance, 2012
- Brighton Collaboration - Case definitions
- Uppsala Monitoring Centre - Tools
Page last reviewed - March 2015.