Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study

• Cristina Morciano ,

  Contributed equally to this work with: Cristina Morciano, Stefania Spila Alegiani

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software, Supervision, Validation, Writing – original draft, Writing – review & editing

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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• Stefania Spila Alegiani ,

  Contributed equally to this work with: Cristina Morciano, Stefania Spila Alegiani

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software, Supervision, Validation, Writing – original draft, Writing – review & editing

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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• Francesca Menniti Ippolito,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Supervision, Validation, Writing – review & editing

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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• Valeria Belleudi,

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Validation, Writing – review & editing

  Affiliation Department of Epidemiology ASL Roma 1, Lazio Regional Health Service, Rome, Italy

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• Gianluca Trifirò,

  Roles Conceptualization, Investigation, Validation, Writing – review & editing

  Affiliation Department of Diagnostics and Public Health, University of Verona, Verona, Italy

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• Giovanna Zanoni,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Immunology Unit, University Hospital, Verona, Italy

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• Aurora Puccini,

  Roles Data curation, Investigation, Validation, Writing – review & editing

  Affiliation Hospital Assistance Service, General Directorate for Personal Care, Health and Welfare, Emilia-Romagna Region, Bologna, Italy

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• Ester Sapigni,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Hospital Assistance Service, General Directorate for Personal Care, Health and Welfare, Emilia-Romagna Region, Bologna, Italy

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• Nadia Mores,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Institute of Pharmacology, Pharmacovigilance, Policlinico Universitario A. Gemelli, Catholic University of Sacred Heart, Rome, Italy

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• Olivia Leoni,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Department of Health of Lombardy Region, Epidemiology Observatory, Milan, Italy

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• Giuseppe Monaco,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Department of Health of Lombardy Region, Epidemiology Observatory, Milan, Italy

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• Elena Clagnan,

  Roles Data curation, Investigation, Validation, Writing – review & editing

  Affiliation Regional Health Authority, Friuli Venezia Giulia Region, Udine, Italy

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• Cristina Zappetti,

  Roles Investigation, Validation, Writing – review & editing

  Affiliation Central Directorate for Health, Social Policies, Friuli Venezia Giulia Region, Trieste, Italy

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• Emanuela Bovo,

  Roles Data curation, Investigation, Validation, Writing – review & editing

  Affiliation Veneto Tumour Registry, Azienda Zero, Padova, Italy

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• Maria Cutillo,

  Roles Data curation, Formal analysis, Investigation, Methodology, Software, Validation, Writing – review & editing

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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• Roberto Da Cas,

  Roles Investigation, Methodology, Software, Validation, Writing – review & editing

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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•  [ ... ],
• Marco Massari

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software, Supervision, Validation, Writing – original draft, Writing – review & editing

  * E-mail: marco.massari@iss.it

  Affiliation Pharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy

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