疫苗不良事件报告系统(VAERS)数据和统计分析所需的协议的有用性被确定为一组关于机器学习建模或探索性分析对VAERS数据的应用建议,并以COVID-19疫苗为例(Pfizer-BioNTech,Moderna,Janssen).共识别出905,976份报告中的262,454份重复报告(29%),合并为643,522份不同的报告。还进行了定制的在线调查,提供了211份报告。首先确定了总共20个最高报告的不良事件。应用各种机器学习算法后的结果差异(关联规则挖掘、自组织地图,分层聚类,双向图)注意到VAERS数据。Moderna报告显示,注射部位相关的AE发生频率较高,达15.2%,与在线调查一致(与Pfizer-BioNTech相比,Moderna的肌肉疼痛报告率高出12%)。AEs{头痛,发热,疲劳,发冷,疼痛,头晕}占总报告的>50%。男性儿童的胸痛报告比女性儿童的胸痛报告高出295%。青霉素和磺胺的频率最高(22%,19%,分别)。对未清理的VAERS数据的分析显示出与上述的主要差异(7%的变化)。发现了过敏中的拼写/语法错误(例如,~14%的报告对青霉素的拼写不正确)。
Usefulness of Vaccine-Adverse Event-Reporting System (VAERS) data and protocols required for statistical analyses were pinpointed with a set of recommendations for the application of machine learning modeling or exploratory analyses on VAERS data with a
case study of COVID-19 vaccines (Pfizer-BioNTech, Moderna, Janssen). A total of 262,454 duplicate
reports (29%) from 905,976
reports were identified, which were merged into a total of 643,522 distinct
reports. A customized online survey was also conducted providing 211
reports. A total of 20 highest reported adverse events were first identified. Differences in results after applying various machine learning algorithms (association rule mining, self-organizing maps, hierarchical clustering, bipartite graphs) on VAERS data were noticed. Moderna reports showed injection-site-related AEs of higher frequencies by 15.2%, consistent with the online survey (12% higher reporting rate for pain in the muscle for Moderna compared to Pfizer-BioNTech). AEs {headache, pyrexia, fatigue, chills, pain, dizziness} constituted >50% of the total reports. Chest pain in male children
reports was 295% higher than in female children
reports. Penicillin and sulfa were of the highest frequencies (22%, and 19%, respectively). Analysis of uncleaned VAERS data demonstrated major differences from the above (7% variations). Spelling/grammatical mistakes in allergies were discovered (e.g., ~14% reports with incorrect spellings for penicillin).