Korea Patient Reported Outcomes Study: mRNA COVID Vaccines 4.3% Severe AEs (Hospitalization)

A group of biomedical researchers in Korea represented by Ju-Young Shin, Ph.D., Sungkyunkwan University, School of Pharmacy assistant professor, editor of Pharmacoepidemiology and Drug Safety and vaccine safety expert, along with colleagues from other major academic medical centers sought to better understand the safety profile of the COVID-19 mRNA vaccines used in this Asian nation, Pfizer-BioNTech and Moderna. These vaccines were administered under emergency authorization with safety profiles not yet clearly defined. With an aim of identifying overall incidence and factors associated with adverse events ensuing after vaccination with one of the mRNA vaccines, the Korean study team designed and executed a web-based survey from December 2-10, via a 2,849 nationwide sampled panel. Study inclusion criteria necessitated persons aged 18-49 years and COVID-19 vaccination at least two weeks prior to the completion of two dosing schedules. The sample was weighted for accurate real-world representation of the national population. Key endpoint for this study: the overall incidence of adverse events after mRNA COVID-19 vaccination plus associated factors. This output was derived via odds ratios generated via the use of multivariable logistic regression models used to identify the factors linked to the adverse events. The individual reported outcome study led to bombshell findings. While 90% of the participants experienced mostly mild AEs, 4.3% experienced severe adverse events requiring hospitalization.

Results of this important study not covered by any western media to date were published in the peer-reviewed Journal of Korean Medical Science.