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.
Drug Saf. 2024 Aug;47(8):783-798. doi: 10.1007/s40264-024-01426-4. Epub 2024 Apr 12.
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.
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.
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.
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.
在 COVID-19 疫苗接种运动期间,向欧洲联盟药物警戒数据库 EudraVigilance 报告了超过 34000 例接种 COVID-19 疫苗后出现重度月经出血的病例。这些报告中超过 90%是由消费者提交的,其余则是由医疗保健专业人员提交的。媒体也报道了 COVID-19 疫苗接种者中关于月经紊乱的公众担忧。我们调查了媒体关注度对 EudraVigilance 报告重度月经出血趋势的影响。
我们使用了自欧洲经济区开始疫苗接种(2021 年 1 月 1 日)到 2022 年 12 月(即监管部门要求将不良事件添加到产品信息之后)期间在欧洲经济区发布的关于月经紊乱和 COVID-19 疫苗的媒体渠道,以及来自 EudraVigilance 的自发报告。
我们发现,监管机构发布的安全更新和随后在媒体渠道上的报道,都先于 EudraVigilance 报告的增加。此外,EudraVigilance 报告的病例中出现的重度月经出血发生在几周或几个月之前,且并非按照发生日期提交的。分析表明,在某些国家,报告重度月经出血的高峰在一定程度上受到媒体报道的影响。
尽管报告行为并非不受媒体影响,但消费者向欧盟自发数据收集系统 EudraVigilance 的报告对于监管安全审查具有很高的价值。这些信息来源可用于调查,以了解公众关注的健康问题的安全背景。