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Ocular inflammatory events following COVID-19 vaccination: reporting of suspected adverse drug reactions to regulatory authorities in the UK
British Journal of Ophthalmology ( IF 3.7 ) Pub Date : 2024-09-01 , DOI: 10.1136/bjo-2023-324503
Ilaria Testi 1, 2 , Taha Soomro 3 , Carlos Pavesio 4 , Ameenat Lola Solebo 5
Affiliation  

Background/aims The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published suspected adverse drug reactions to vaccines against COVID-19. Ocular inflammatory events following COVID-19 vaccination have been reported worldwide. Methods We analysed MHRA data on spontaneous reports of suspected ocular inflammatory events following COVID-19 vaccination between January 2021 and September 2022. Results The MHRA received 300 UK spontaneous suspected reports of ocular inflammatory events following COVID-19 vaccination, with a calculated prevalence of 6.6 events per 1 000 000 vaccinated individuals. Anterior uveitis was the most common phenotype (58.3%), followed by optic neuritis in 39.3%. Median number of days between vaccination and onset was 8 days. Resolution of the event was seen in 52.3%. Conclusion Ocular inflammatory events following COVID-19 vaccination have a very rare prevalence in the UK. There is no increase in the reporting rate of uveitis, optic neuritis and scleritis following COVID-19 vaccination when compared with the range of incidence in the UK population. The Yellow Card System represents a vital instrument within the domain of pharmacovigilance, empowering patients and healthcare professionals to contribute to the ongoing monitoring of medication safety. Data are available upon reasonable request.

中文翻译:


COVID-19 疫苗接种后的眼部炎症事件:向英国监管机构报告可疑药物不良反应



背景/目标 英国药品和保健品监管局 (MHRA) 发布了针对 COVID-19 疫苗的疑似不良药物反应。全球范围内均有报告称,接种 COVID-19 疫苗后会出现眼部炎症事件。方法 我们分析了 MHRA 2021 年 1 月至 2022 年 9 月期间关于 COVID-19 疫苗接种后疑似眼部炎症事件自发报告的数据。结果 MHRA 收到了 300 份英国 COVID-19 疫苗接种后疑似眼部炎症事件自发报告,计算出患病率为 6.6每 1 000 000 名接种疫苗者的事件数。前葡萄膜炎是最常见的表型(58.3%),其次是视神经炎(39.3%)。接种疫苗和发病之间的中位天数为 8 天。该事件的解决率为 52.3%。结论 在英国,接种 COVID-19 疫苗后发生的眼部炎症事件非常罕见。与英国人口的发病范围相比,接种 COVID-19 疫苗后葡萄膜炎、视神经炎和巩膜炎的报告率没有增加。黄卡系统是药物警戒领域的重要工具,使患者和医疗保健专业人员能够为持续监测药物安全做出贡献。数据可根据合理要求提供。
更新日期:2024-08-22
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