The vaccine adverse event reporting system (VAERS) is a vital resource for post-licensure vaccine safety monitoring and has played a key role in assessing the safety of COVID-19 vaccines. However it is difficult to properly identify rare adverse events (AEs) associated with vaccines due to small or zero counts. We propose a Bayesian model with a Dirichlet Process Mixture prior to improve accuracy of the AE estimates with small counts by allowing data-guided information sharing between AE estimates. We also propose a negative control procedure embedded in our Bayesian model to mitigate the reporting bias due to the heightened awareness of COVID-19 vaccines, and use it to identify associated AEs as well as associated AE groups defined by the organ system in the Medical Dictionary for Regulatory Activities (MedDRA) ontology. The proposed model is evaluated using simulation studies, in which it outperforms baseline models without information sharing and is applied to study the safety of COVID-19 vaccines using VAERS data.

翻译：暂无翻译