Public Health Evaluation and Projection/Vaccine Safety Evaluation, National Institute for Health and Welfare

The objective of this nationwide,population-based project is to evaluate vaccine safety in Finland. More detailed aims are to detect potential vaccine safety signals,to validate the signals,and if needed,to test hypotheses with full epidemiological analyses. Analytical methods for safety monitoring will be further developed.The study population will include the entire Finnish population for selected vaccinations and outcomes. The data are mainly based on the national health registers. The exposure data will be obtained from the National Vaccination Register and e-prescription data maintained by THL. The outcomes will be collected from Hospital Inpatient (HILMO) and Outpatient care registers (AvoHILMO). These will be complemented with data from Birth and Malformation Registers,Social Insurance Institution registers,population statistics,and patient files.HILMO and AvoHILMO will be used for exploration of a large range of diagnoses to detect potential safety signals.