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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: Participation in advisory boards and seminars on topics not related to this paper and sponsored by the following pharmaceutical companies in the last two years: UCB, MSD, Eli Lilly; Sanofi; Amgen; Novo Nordisk; Sobi; Gilead; Celgene; Daikii Sankyo. Scientific coordinator of the UNIVR academic spin-off INSPIRE that in the last two years carried out observational studies\/systematic reviews on topics not related to the content of this paper and which were funded by Novo Nordisk, Kiowa Kirin, Shionogi, and Daiichi Sankyo, Consultant for Viatris in a judicial proceeding, the subject of which is not related to the topic of this paper. Professor Gianluca Trifir\u00f2 is an Editorial Board member of Drug Safety. Gianluca Trifir\u00f2 was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L\u2019Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco B. Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichov\u00e1, Andreea Farcas, Giele-Eshuis Janneke have no conflicts of interest that are directly relevant to the content of this article. The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, The Netherlands. Scientific work for this project was coordinated by the University Medical Center Utrecht in collaboration with the Vaccine Monitoring Collaboration for Europe network (VAC4EU). The project has received support from the European Medicines Agency under the Framework service contract nr EMA\/2018\/23\/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Open access funding provided by Universit\u00e0 degli Studi di Verona within the CRUI-CARE Agreement. This research was supported by the European Medicines Agency.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The study reports with results are available in Supplementary Materials and in reference 10, section \u201cMethodological aspects\u201d (. The datasets for this manuscript are not publicly available. Requests to access the datasets should be directed and motivated to the first author and will be granted upon reasonable request and permission from partners.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability statement"}},{"value":"Code availability will be granted upon reasonable request and permission from partners.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"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. Portugal: EC ref. no. 74\/2021. Romania: EC ref. no. AVZ6; 08\/11\/2021 and 246; 30\/06\/2021. Slovakia: Trieda SNP 1,040 11 Kosice; 1\/12\/2021. Spain: 21\/208-PCV; 29\/09\/2021. The UK: EC ref. no. 21\/HRA\/2077.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"The members of the \u201cilmiovaccinoCOVID19 collaborating group\u201d are listed in the Supplementary Materials.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Additional information"}},{"value":"Informed consent was obtained from all subjects involved in the study.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate (include appropriate statements)"}},{"value":"In order to participate in this study, we need your consent. Furthermore, you will be asked to provide some general details. As soon as the informed consent has been sent, you will receive an e-mail with an activation link. Once this link has been clicked, the participation is confirmed and definitive. You will receive the first questionnaire, which can be filled in immediately. The activation link is valid for a maximum of 48 h. For questions, please contact the study team at [name organisation] via [email organisation] or [telephone number organisation]. I have read the privacy statement and the information regarding this research. Any and all questions I had were answered by contacting [name organisation]. I understand that participation is voluntary. Furthermore, I understand that I can decide at any moment to stop my participation in this research and do not need to give a reason for my decision. I understand that all information will be treated with strict confidentiality. I give permission for my data to be used for the purpose of this research; namely, to gather information and expand knowledge on possible symptoms which can occur after receiving the corona vaccine. It is important for [name organisation] to know precisely which vaccine was given in order to compare the reported symptoms between the given corona vaccines. Gaining more insight in the relevant medical history of participants, reported symptoms, the nature of these symptoms, the course of these symptoms, possible risk factors and the consequences related to health (Available at  Annex 2: example of informed consent).","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent statements"}},{"value":"Consent for publication was obtained from all subjects involved in the study.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication (include appropriate statements)"}},{"value":"\u201cI give permission for my data to be used for the purpose of this research, namely, to gather information and expand knowledge on possible symptoms which can occur after receiving the corona vaccine.\u201d (Available at  Annex 2: example of informed consent)","order":11,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication statements"}},{"value":"Conceptualisation: Gianluca Trifir\u00f2. Formal analysis: Chiara Bellitto, Luca L\u2019Abbate, Thomas Lieber, Erik Mulder; Investigation: Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Monika Raethke, Florence van Hunsel, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco B. Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichov\u00e1, Andreea Farcas, Giele-Eshuis Janneke, Miriam C. Sturkenboom. Data curation: Monika Raethke, Florence van Hunsel, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco B. Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichov\u00e1, Andreea Farcas, Giele-Eshuis Janneke, Miriam C. Sturkenboom. Writing, original draft: Chiara Bellitto, Nicoletta Luxi, Gianluca Trifir\u00f2. Writing, review & editing: Francesco Ciccimarra, Monika Raethke, Florence van Hunsel, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco B. Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichov\u00e1, Andreea Farcas, Giele-Eshuis Janneke, Miriam C. Sturkenboom. Visualisation: Chiara Bellitto, Francesco Ciccimarra. Supervision: Miriam C. Sturkenboom, Gianluca Trifir\u00f2. All authors have read and agreed to the published version of the manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":12,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data contribution"}}]}}