{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:12:35Z","timestamp":1791418355682,"version":"4.3.3"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2023,4,1]],"date-time":"2023-04-01T00:00:00Z","timestamp":1680307200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2023,4,1]],"date-time":"2023-04-01T00:00:00Z","timestamp":1680307200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","award":["EMA\/2018\/28\/PE"],"award-info":[{"award-number":["EMA\/2018\/28\/PE"]}],"id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]},{"name":"the Agency for Medicinal Products and Medical Devices of Croatia"},{"name":"Paul-Ehrlich-Institut"},{"name":"Minist\u00e8re de la Sant\u00e9 et des Solidarit\u00e9s and the Minist\u00e8re de l\u2019Enseignement sup\u00e9rieur, de la Recherche et de l\u2019Innovation"},{"DOI":"10.13039\/501100002999","name":"Ministerie van Volksgezondheid, Welzijn en Sport","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002999","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2023,4]]},"DOI":"10.1007\/s40264-023-01281-9","type":"journal-article","created":{"date-parts":[[2023,4,7]],"date-time":"2023-04-07T03:55:04Z","timestamp":1680839704000},"page":"391-404","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose"],"prefix":"10.1007","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5334-1840","authenticated-orcid":false,"given":"Monika","family":"Raethke","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8965-3224","authenticated-orcid":false,"given":"Florence","family":"van Hunsel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3589-0819","authenticated-orcid":false,"given":"Nicolas H.","family":"Thurin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3643-683X","authenticated-orcid":false,"given":"Caroline","family":"Dureau-Pournin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Mentzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Kova\u010di\u0107","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikica","family":"Miro\u0161evi\u0107 Skvrce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelien","family":"De Clercq","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2824-1087","authenticated-orcid":false,"given":"Martine","family":"Sabbe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1147-7296","authenticated-orcid":false,"given":"Gianluca","family":"Trifir\u00f2","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicoletta","family":"Luxi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexia","family":"Giovanazzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saad","family":"Shakir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olaf H.","family":"Klungel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandor","family":"Schmikli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1360-2388","authenticated-orcid":false,"given":"Miriam","family":"Sturkenboom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,7]]},"reference":[{"issue":"27","key":"1281_CR1","doi-asserted-by":"publisher","first-page":"2603","DOI":"10.1056\/NEJMoa2034577","volume":"383","author":"FP Polack","year":"2020","unstructured":"Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603\u201315. https:\/\/doi.org\/10.1056\/NEJMoa2034577.","journal-title":"N Engl J Med"},{"issue":"10269","key":"1281_CR2","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1016\/S0140-6736(20)32661-1","volume":"397","author":"M Voysey","year":"2021","unstructured":"Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99\u2013111. https:\/\/doi.org\/10.1016\/S0140-6736(20)32661-1.","journal-title":"Lancet"},{"issue":"1","key":"1281_CR3","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1038\/s41541-021-00336-1","volume":"6","author":"I McDonald","year":"2021","unstructured":"McDonald I, Murray SM, Reynolds CJ, Altmann DM, Boyton RJ. Comparative systematic review and meta-analysis of reactogenicity, immunogenicity and efficacy of vaccines against SARS-CoV-2. NPJ Vaccines. 2021;6(1):74. https:\/\/doi.org\/10.1038\/s41541-021-00336-1.","journal-title":"NPJ Vaccines."},{"key":"1281_CR4","unstructured":"European Medicines Agency (EMA). SmPC Comirnaty. 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/comirnaty-epar-product-information_en.pdf Accessed 14 July 2022."},{"issue":"1","key":"1281_CR5","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1136\/bmjebm-2020-111507","volume":"27","author":"S Dhanda","year":"2022","unstructured":"Dhanda S, Osborne V, Lynn E, Shakir S. Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK? BMJ Evid Based Med. 2022;27(1):1\u20136. https:\/\/doi.org\/10.1136\/bmjebm-2020-111507.","journal-title":"BMJ Evid Based Med."},{"issue":"10","key":"1281_CR6","doi-asserted-by":"publisher","first-page":"1941","DOI":"10.1016\/j.vaccine.2010.12.123","volume":"29","author":"L Harmark","year":"2011","unstructured":"Harmark L, van Hunsel F, Hak E, van Grootheest K. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine. 2011;29(10):1941\u20137. https:\/\/doi.org\/10.1016\/j.vaccine.2010.12.123.","journal-title":"Vaccine"},{"issue":"21","key":"1281_CR7","doi-asserted-by":"publisher","first-page":"2201","DOI":"10.1001\/jama.2021.5374","volume":"325","author":"J Chapin-Bardales","year":"2021","unstructured":"Chapin-Bardales J, Gee J, Myers T. Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines. JAMA. 2021;325(21):2201\u20132. https:\/\/doi.org\/10.1001\/jama.2021.5374.","journal-title":"JAMA"},{"issue":"7","key":"1281_CR8","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/S1473-3099(21)00224-3","volume":"21","author":"C Menni","year":"2021","unstructured":"Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939\u201349. https:\/\/doi.org\/10.1016\/S1473-3099(21)00224-3.","journal-title":"Lancet Infect Dis"},{"issue":"12","key":"1281_CR9","doi-asserted-by":"publisher","first-page":"e2140364","DOI":"10.1001\/jamanetworkopen.2021.40364","volume":"4","author":"AL Beatty","year":"2021","unstructured":"Beatty AL, Peyser ND, Butcher XE, Cocohoba JM, Lin F, Olgin JE, et al. Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination. JAMA Netw Open. 2021;4(12):e2140364. https:\/\/doi.org\/10.1001\/jamanetworkopen.2021.40364.","journal-title":"JAMA Netw Open"},{"key":"1281_CR10","unstructured":"Brighton Collaboration. COVID-19 AESI list. 2020. https:\/\/brightoncollaboration.us\/wp-content\/uploads\/2021\/01\/COVID-19-updated-AESI-list.pdf. Accessed 11 Oct 2021."},{"issue":"5","key":"1281_CR11","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1056\/NEJMoa2035389","volume":"384","author":"LR Baden","year":"2021","unstructured":"Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403\u201316. https:\/\/doi.org\/10.1056\/NEJMoa2035389.","journal-title":"N Engl J Med"},{"issue":"9","key":"1281_CR12","doi-asserted-by":"publisher","first-page":"847","DOI":"10.1056\/NEJMoa2117608","volume":"386","author":"J Sadoff","year":"2022","unstructured":"Sadoff J, Gray G, Vandebosch A, C\u00e1rdenas V, Shukarev G, Grinsztejn B, et al. Final analysis of efficacy and safety of single-dose Ad26COV2.S. N Engl J Med. 2022;386(9):847\u201360. https:\/\/doi.org\/10.1056\/NEJMoa2117608.","journal-title":"N Engl J Med"},{"key":"1281_CR13","unstructured":"The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Welcome to MedDRA. 2021. https:\/\/www.meddra.org\/. Accessed 14 July 2022."},{"key":"1281_CR14","unstructured":"The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. MedDRA\u00ae POINTS TO CONSIDER COMPANION DOCUMENT ICH-Endorsed Guide for MedDRA Users. 2022. https:\/\/admin.meddra.org\/sites\/default\/files\/guidance\/file\/000515_companionptc_r2_0_Oct2020.pdf Accessed 28 Jan 2022."},{"key":"1281_CR15","unstructured":"CIOMS Working Group VIII. Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII. Geneva2010. Report No.: 9290360828."},{"key":"1281_CR16","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.4036376","author":"C Willame","year":"2022","unstructured":"Willame C, Dodd C, Carlos D, Roel E, Gini R, Bartolini C, et al. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European Healthcare Databases\u2014an ACCESS Cohort Study. SSRN Electron J. 2022. https:\/\/doi.org\/10.2139\/ssrn.4036376.","journal-title":"SSRN Electron J"},{"key":"1281_CR17","unstructured":"European Medicines Agency (EMA). SmPC Spikevax. 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/spikevax-previously-covid-19-vaccine-moderna-epar-product-information_en.pdf. Accessed 14 July 2022."},{"key":"1281_CR18","unstructured":"European Medicines Agency (EMA). SmPC Vaxzevria 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en.pdf Accessed 14 July 2022."},{"key":"1281_CR19","unstructured":"European Medicines Agency (EMA). SmPC Covid-19 vaccine Janssen (Jcovden). 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/covid-19-vaccine-janssen-epar-product-information_en.pdf. Accessed 14 July 2022."},{"key":"1281_CR20","volume-title":"Web-based Intensive Monitoring; a patient based pharmacovigilance tool (Thesis)","author":"L Harmark","year":"2012","unstructured":"Harmark L. Web-based Intensive Monitoring; a patient based pharmacovigilance tool (Thesis). Rijksuniversiteit Groningen; 2012."},{"issue":"5","key":"1281_CR21","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1002\/pds.875","volume":"12","author":"L Zhou","year":"2003","unstructured":"Zhou L, Harrison-Woolrych M, Coulter DM. Use of the New Zealand Intensive Medicines Monitoring Programme to study the levonorgestrel-releasing intrauterine device (Mirena). Pharmacoepidemiol Drug Saf. 2003;12(5):371\u20137. https:\/\/doi.org\/10.1002\/pds.875.","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"5","key":"1281_CR22","doi-asserted-by":"publisher","first-page":"801","DOI":"10.1111\/j.1365-2125.2011.04142.x","volume":"73","author":"IS Mackenzie","year":"2012","unstructured":"Mackenzie IS, MacDonald TM, Shakir S, Dryburgh M, Mantay BJ, McDonnell P, et al. Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes. Br J Clin Pharmacol. 2012;73(5):801\u201311. https:\/\/doi.org\/10.1111\/j.1365-2125.2011.04142.x.","journal-title":"Br J Clin Pharmacol"},{"issue":"19","key":"1281_CR23","doi-asserted-by":"publisher","first-page":"2283","DOI":"10.1016\/j.vaccine.2015.03.014","volume":"33","author":"L van Balveren-Slingerland","year":"2015","unstructured":"van Balveren-Slingerland L, Kant A, Harmark L. Web-based intensive monitoring of adverse events following influenza vaccination in general practice. Vaccine. 2015;33(19):2283\u20138. https:\/\/doi.org\/10.1016\/j.vaccine.2015.03.014.","journal-title":"Vaccine"},{"issue":"4","key":"1281_CR24","doi-asserted-by":"publisher","first-page":"319","DOI":"10.1007\/s40264-022-01151-w","volume":"45","author":"A Kant","year":"2022","unstructured":"Kant A, Jansen J, van Balveren L, van Hunsel F. Description of frequencies of reported adverse events following immunization among four different COVID-19 vaccine brands. Drug Saf. 2022;45(4):319\u201331. https:\/\/doi.org\/10.1007\/s40264-022-01151-w.","journal-title":"Drug Saf"},{"issue":"10","key":"1281_CR25","doi-asserted-by":"publisher","first-page":"2286","DOI":"10.1002\/eji.201546178","volume":"46","author":"M Pinti","year":"2016","unstructured":"Pinti M, Appay V, Campisi J, Frasca D, Fulop T, Sauce D, et al. Aging of the immune system: Focus on inflammation and vaccination. Eur J Immunol. 2016;46(10):2286\u2013301. https:\/\/doi.org\/10.1002\/eji.201546178.","journal-title":"Eur J Immunol"},{"key":"1281_CR26","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-021-01138-z","author":"RE Ferner","year":"2022","unstructured":"Ferner RE, Stevens RJ, Anton C, Aronson JK. Spontaneous reporting to regulatory authorities of suspected adverse drug reactions to COVID-19 vaccines over time: the effect of publicity. Drug Saf. 2022. https:\/\/doi.org\/10.1007\/s40264-021-01138-z.","journal-title":"Drug Saf"},{"key":"1281_CR27","unstructured":"European Medicines Agency (EMA). Vaxzevria: further advice on blood clots and low blood platelets. 2021. https:\/\/www.ema.europa.eu\/en\/news\/vaxzevria-further-advice-blood-clots-low-blood-platelets. Accessed 14 July 2022."},{"key":"1281_CR28","doi-asserted-by":"publisher","first-page":"n699","DOI":"10.1136\/bmj.n699","volume":"372","author":"J Wise","year":"2021","unstructured":"Wise J. Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots. BMJ. 2021;372:n699. https:\/\/doi.org\/10.1136\/bmj.n699.","journal-title":"BMJ"}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-023-01281-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-023-01281-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-023-01281-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,18]],"date-time":"2023-04-18T11:10:58Z","timestamp":1681816258000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-023-01281-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4]]},"references-count":28,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,4]]}},"alternative-id":["1281"],"URL":"https:\/\/doi.org\/10.1007\/s40264-023-01281-9","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4]]},"assertion":[{"value":"19 February 2023","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 April 2023","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"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. The project has received support from the European Medicines Agency under the Framework service contract nr EMA\/2018\/28\/PE. This document expresses the opinions of the authors of the paper, 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. In Croatia, the study was funded partially by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). In Germany, the SafeVac 2.0 study was funded by the German ministry of Health and conducted by Paul-Ehrlich-Institut the national competed authority for vaccines and biomedicinal products in Germany. The French part of the study, named EVANESCO, was partially funded by the European Medicines Agency. In France, EVANESCO was identified as a National research priority (<i>priorit\u00e9 nationale de recherche<\/i>) by the 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> The Dutch part of the study was funded by a grant from the Dutch Ministry of Health, Welfare and Sport. The Dutch Ministry of Health, Welfare and Sport had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. In the United Kingdom the project was funded by the European Medicines Agency through the cohort event monitoring project.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Nicolas Thurin and Caroline Dureau-Pournin work for Bordeaux PharmacoEpi, an independent research platform of the Bordeaux University and its subsidiary the ADERA, which performs financially supported studies for public and private partners, in compliance with the ENCePP Code of Conduct. Miriam Sturkenboom and Sandor Schmikli work for the University Medical Center Utrecht, which performs COVID-19 vaccine trials and post-licensure vaccine effectiveness and safety studies for public and private organisations, according to ENCePP code of conduct of scientific independence. Gianluca Trifir\u00f2 reported to advisory boards on topics not related to this presentation and was sponsored by the following pharmaceutical companies in the last two years: Eli Lilly, Sanofi, Amgen, Novo Nordisk, Sobi, Gilead, Celgene, Daikii Sankyo.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/Competing interests"}},{"value":"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":"Availability of data and material"}},{"value":"The structured query language (SQL) statements for the data used in this article 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":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The study in Belgium was approved by the Ethics Committee Research of University Hospitals Leuven. The study in Croatia received approval from Central Ethics Committee (CEC). The study in France was approved by the <i>Comit\u00e9 de Protection des personnes<\/i> (CPP \u2013 21.00821.210217) and the <i>Commission nationale de l'informatique et des libert\u00e9s<\/i> (CNIL \u2013 DR-2021-209) under the name EVANESCO. If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the central committee on research involving human subjects (CCMO). After submission to an accredited review committee (METC Brabant), this study was deemed not to fall under the WMO act. The study in the UK was approved by the London \u2013 Brent Research Ethics Committee (REC reference: 21\/HRA\/2077) & obtained HRA and Health and Care Research Wales (HCRW) Approval. The study in Germany was approved by the Ethics Committee at the Regional Medical Council of Hessen. Participants in the study provided the consent electronically via the smartphone application. The study in Italy was approved by the <i>Comitato Etico dell\u2019Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.<\/i> under the name \u201cCohort Event Monitoring of safety of COVID-19 vaccines\u201d.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Participants in the study provided written informed consent before participation to the study.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Participants in the study provided a written statement of consent at the time of registration for their data to be used for the purpose of this research and publication of study results.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The original study protocol was designed by all authors. The queries and dataset were established by MR. Data analysis was performed by MR and FHL. The design of the manuscript was determined by MR, FHL and MS. All authors contributed to the manuscript drafting and revision. All authors approved the final version to be published and agree to be accountable for the work they performed and the methods and reporting of results.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"This content has been made available to all.","name":"free","label":"Free to read"}]}}