Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes FRESH-PEF73996-en Cécile DROZ-PERROTEAU Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes EVANESCO FRESH-PEF73996-en 73996 FRESH-PEF73996 Caroline DUREAU-POURNIN INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) UNIVERSITE DE BORDEAUX Epidemiology France Portal (PEF) MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES null COVID-19 vaccines adverse drug reactions Infectious disease medicine COVID-19 Healthcare system determinants: Use of care Healthcare system determinants To generate incidence rates of patient-reported Adverse Drug Reaction (ADR) of brand specific COVID-19 vaccination in France, in near real time. null France Individuals General population Male Female Child (6 to 12 years) Young Adult (19 to 24 years) Adult (25 to 44 years) Middle Aged (45 to 64 years) Aged (65 to 79 years) Aged, 80 and over (80 years and more) To describe ADR incidence rates according to brand of vaccine and to specific populations such as, pregnant women, patients with severe co-morbidities (e.g., frail, vaccinees with auto-immune diseases), elderly, children, patients having recently received other vaccines; - To detect potential novel safety signals; - To identify possible risk factors for ADR. Participant-reported health data MedDRA coding of adverse reactions Health event/morbidity Health event/mortality Others Other Through organizations (health services or institutions schools businesses etc.) [1000-10000[ individuals Interview with the participant (including clinical) Observational Study Observational Study Cohort study 6,640 vaccinated individuals in France Unknown To be defined