Department of Computer Science and Engineering, California State University San Bernardino, 5500 University Parkway, San Bernardino, CA 92407, USA.
School of Computer Science and Mathematics, Liverpool John Moores University, Liverpool L3 3AF, UK.
Int J Mol Sci. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235.
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).
疫苗不良事件报告系统（VAERS）数据的有用性和进行统计分析所需的方案已被确定，并针对 COVID-19 疫苗（辉瑞-生物科技、莫德纳、强生）的 VAERS 数据应用机器学习建模或探索性分析提出了一系列建议。从 905976 份报告中发现了 262454 份（29%）重复报告，并将其合并为总共 643522 份不同的报告。还进行了一项定制的在线调查，提供了 211 份报告。首先确定了报告频率最高的 20 种不良事件。在 VAERS 数据上应用各种机器学习算法（关联规则挖掘、自组织映射、层次聚类、二分图）后，注意到结果存在差异。莫德纳报告显示，注射部位相关不良事件的频率高出 15.2%，与在线调查结果一致（与辉瑞-生物科技相比，莫德纳的肌肉疼痛报告率高出 12%）。不良事件{头痛、发热、疲劳、寒战、疼痛、头晕}构成了总报告的 50%以上。男性儿童胸痛报告比女性儿童高 295%。青霉素和磺胺类药物的报告频率最高（分别为 22%和 19%）。对未清洗的 VAERS 数据进行分析表明，与上述结果存在较大差异（变化幅度为 7%）。还发现了过敏反应中的拼写/语法错误（例如，约 14%的青霉素报告存在拼写错误）。
