| アブストラクト | BACKGROUND AND OBJECTIVE: During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of COVID-19 vaccines originating in the Economic European Area were submitted to EudraVigilance, the European Union database of suspected adverse drug reactions. More than 90% of these reports were sent by consumers while the remaining by healthcare professionals. Public concerns regarding menstruation disorders in COVID-19 vaccinees were also covered by the media. We investigated the impact of media attention on the reporting trends of heavy menstrual bleeding to EudraVigilance. METHODS: We used media outlets published in the Economic European Area on menstrual disorders and COVID-19 vaccines from the beginning of the vaccination campaign in the Economic European Area (1 January, 2021) until December 2022 (i.e., after the regulatory request to add the adverse event to the product information) and spontaneous reports from EudraVigilance. RESULTS: We found that the publication of safety updates from regulatory authorities and subsequent coverage in media outlets preceded increased reporting to EudraVigilance. Furthermore, the heavy menstrual bleeding reported in the cases occurred several weeks or months earlier and were not submitted to the respective date. The analysis suggests that the spikes in reporting of heavy menstrual bleeding were to some extent influenced by media coverage in some countries. CONCLUSIONS: Consumer reporting to the European Union spontaneous data collection system, EudraVigilance, was of high value for regulatory safety reviews, albeit the reporting behaviours were not free of the influence of the media. These sources of information can be investigated to understand the context of safety concerns of public health interest. |
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| 投稿者 | Gordillo-Maranon, Maria; Szmigiel, Agnieszka; Yalmanova, Vladimira; Caplanusi, Irina; Genov, Georgy; Olsen, David Benee; Straus, Sabine |
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| 組織名 | Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The;Netherlands.;Institute of Cardiovascular Science, Faculty of Population Health, University;College London, London, UK.;Pharmacovigilance Office, European Medicines Agency, Domenico Scarlattilaan 6,;1083 HS, Amsterdam, The Netherlands. agnieszka.szmigiel@ema.europa.eu.;Stakeholders and Communication, European Medicines Agency, Amsterdam, The;1083 HS, Amsterdam, The Netherlands.;Department of Pharmacovigilance, Norwegian Medical Products Agency, Oslo, Norway.;Medicines Evaluation Board (MEB), Utrecht, The Netherlands.;Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The |
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