To strengthen vaccine safety monitoring in all countries
Effective spontaneous reporting of adverse events following immunization (AEFI) is the first step to making sure that vaccine products are safe and are being safely administered. Yet almost half the world’s population lives in countries without an effective system for monitoring the safety of vaccines. The Global Vaccine Safety Initiative (GVSI) aims to ensure that monitoring of vaccine safety takes place even in low-resource settings.
Severe reactions following immunization are extremely rare so several countries have joined forces to pool their AEFI data in a common global database. The database is managed by the WHO Programme for International Drug Monitoring. Experience shows that most severe AEFI are not true vaccine reactions; rather, they are coincidental occurrences of health events or the anxiety associated with receipt of a vaccine.
The goal is that all countries should at least have a system for spontaneous reporting of AEFI and for investigating those that are serious. Countries that manufacture vaccines and countries where newly available vaccines are being introduced should have additional capacity for vaccine pharmacovigilance.
Procedures and tools
- Adverse events following immunization (AEFI)
- Information for health-care workers - managing adverse events
- Other AEFI-related topics
AEFI Core Variables
Sample AEFI reporting form using core variables