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Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes

France, 2021 - 2023
Reference ID
FRESH-PEF73996-en
Producer(s)
Caroline;DUREAU-POURNIN
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
41
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access

    • Identification

    Survey ID number

    FRESH-PEF73996-en
    Title

    Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes
    Abbreviation or Acronym

    EVANESCO
    Country
    Name Country code
    France fr
    Kind of Data

    ['Participant-reported health data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Infectious disease medicine health theme
    COVID-19 cim-11
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    COVID-19 vaccines adverse drug reactions

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Child (6 to 12 years)","concept":{"vocab":"MeSH","vocabURI":"D002648"}},{"value":"Adolescent (13 to 18 years)","concept":{"vocab":"MeSH","vocabURI":"D000293"}},{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"General population","level_type_clusion_other":"","clusion_I":"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.","clusion_E":""}

    Producers and sponsors

    Primary investigators
    Name
    Caroline;DUREAU-POURNIN
    Producers
    Name Role
    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) sponsor
    UNIVERSITE DE BORDEAUX sponsor
    Funding Agency/Sponsor
    Name
    MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES
    Other Identifications/Acknowledgments
    Name
    European consortium coordinated by Utrecht University, Netherlands; Participant Centres: Pharmacovigilance Centre LAREB, Netherlands; Federal Agency for Medicines and Health Products, Belgium; Luxembourg Institute of Health, Luxembourg; University of Verona, Italy; University of Bordeaux, France; DSRU, England; Paul Ehrlich Institute, Germany; HALMED, Croatia

    Study authorization

    Agency
    Agency name
    CPP
    ANSM

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']
    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2021-01-01 2023-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Others

    Quality standards

    Quality standards
    Standard
    ['MedDRA coding of adverse reactions']

    Data Access

    Availability Status

    {"value":"To be defined","extLink":[]}
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