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The project has received partial support from the European Medicines Agency (EMA) under the Framework service contract nr EMA\/2018\/23\/PE. The content of this paper expresses the opinion of the authors. It may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. The French part of this research, named EVANESCO, was identified as a \u201cnational research priority\u201d (<i>priorit\u00e9 nationale de recherche)<\/i> by the <i>Comit\u00e9 ad-hoc de pilotage national des essais th\u00e9rapeutiques et autres recherches sur le COVID-19<\/i> (CAPNET), and received a complementary funding from the <i>Minist\u00e8re de la Sant\u00e9 et des Solidarit\u00e9s<\/i> and the <i>Minist\u00e8re de l\u2019Enseignement sup\u00e9rieur, de la Recherche et de l\u2019Innovation.<\/i>","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Miriam Sturkenboom is head of a department that conducts studies for regulatory agencies and pharmaceutical companies, with research grants to the institution; this includes Pfizer, Janssen and AstraZeneca. All studies are conducted using the ENCePP code of conduct. Gianluca Trifir\u00f2 has served in the last three years on advisory boards\/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master's program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received a non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also the scientific coordinator of the academic spin-off \"INSPIRE srl\" which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). None of these listed activities is related to the topic of the manuscript. Fariba Ahmadizar is the principal investigator of a Janssen COVID-19 vaccine safety study. None of the other authors has any conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Netherlands: EC ref number NW2021-04. France: CNIL ref. no. MLD\/MFI\/AR218727, EC ref. no. 2020-A03554-35. Italy: PARERE N. 463 del Registro delle Sperimentazioni 2020\/2021.\u00a0Portugal: EC ref. no. 74\/2021.\u00a0Romania: EC ref. no. AVZ6; 08\/11\/2021 and 246; 30\/06\/2021.\u00a0Slovakia: Trieda SNP 1,040 11 Kosice; 1\/12\/2021.\u00a0Spain: 21\/208-PCV; 29\/09\/2021. The UK: EC ref. no. 21\/HRA\/2077.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained\u00a0from participants, parents or legal guardians.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Original data will be available upon request, including coding of medicinal products and adverse events to standardised dictionaries.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"The code used to retrieve the dates of the reports from EudraVigilance will be made available on reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors contributed to the study's conception and design. Material preparation, data collection and analysis were performed by [Nicoletta Luxi], [Monika Raethke]. The first manuscript draft was written by [Fariba Ahmadizar], and all authors commented on previous versions. All authors read and approved the final version.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}