Mitchell Joseph, Yue Qun-Ying
Uppsala Monitoring Centre, Bredgränd 7, Uppsala 753 20, Sweden.
Vaccine X. 2021 Dec;9:100122. doi: 10.1016/j.jvacx.2021.100122. Epub 2021 Nov 3.
This study reviewed cases of appendicitis following administration of COVID-19 vaccines reported to VigiBase, the WHO database of individual case safety reports (ICSRs). Three hundred fifty-eight cases were identified, and disproportionate reporting was noted, with 329 calculated expected cases. Upon review, 24 ICSRs were excluded, so 334 unique ICSRs underwent clinical review from 19 countries. Forty-eight percent of ICSRs reported imaging and 69% noted surgical intervention. The cases were clinically coherent, with an apparent increase in reporting in the four days post-vaccination and a possible dose-response relationship. Appendicitis has been suggested as an adverse event of special interest post-vaccination against COVID-19 after a numerical increase in the vaccine arm of a clinical trial. The case series may be affected by differences in global patterns of reporting, and it is not possible to prove nor disprove causality from this case series. Global longitudinal studies are required to clarify any possible relationship.
本研究回顾了向世界卫生组织个体病例安全报告(ICSR)数据库VigiBase报告的接种新冠疫苗后发生阑尾炎的病例。共识别出358例病例,发现报告比例失衡,预期病例数为329例。经审查,排除了24份ICSR,因此对来自19个国家的334份独特的ICSR进行了临床审查。48%的ICSR报告了影像学检查,69%提到了手术干预。这些病例在临床上具有连贯性,接种疫苗后四天内报告明显增加,且可能存在剂量反应关系。在一项临床试验的疫苗组中,阑尾炎病例数出现增加后,有人提出阑尾炎是接种新冠疫苗后的一个特别关注的不良事件。该病例系列可能受到全球报告模式差异的影响,无法从这个病例系列中证明或反驳因果关系。需要进行全球纵向研究以阐明任何可能的关系。