The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged \>18 years in Indonesia.
To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization. To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.
Study Type
OBSERVATIONAL
Enrollment
1,100
Jakarta Provincial Ministry of Health
Jakarta, DKI Jakarta, Indonesia
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.
Time frame: Within 30 minutes after vaccination
Local reaction and systemic events occurring within 30 minutes after each immunization.
Number and percentage of subjects with at least one of these adverse events, solicited or not, within 30 minutes after vaccination.
Time frame: Within 30 minutes after vaccination
Local reaction and systemic events occurring within 28 days after immunization
Number and percentage of subjects with at least one of these adverse events, solicited or not, within 28 days after vaccination.
Time frame: 28 days
Any serious adverse event during observation period.
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.