1COVID-19 Vaccine Safety Research Center, Seoul, Korea
2Department of Health Convergence, College of Science & Industry Convergence, Ewha Womans University, Seoul, Korea
3Department of Preventive Medicine, College of Medicine, Graduate Program in System Health Science & Engineering, Ewha Womans University, Seoul, Korea
4National Academy of Medicine of Korea, Seoul, Korea
5Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Korea
6Department of Radiology, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
7Department of Social and Preventive Medicine, Hallym University College of Medicine, Chuncheon, Korea
8Department of Infectious Diseases, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea
9Department of Physiology, Korea University College of Medicine, Seoul, Korea
© 2023 Korea Disease Control and Prevention Agency.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Ethics Approval
This study was approved by the Public Institutional Review Board Designated by Ministry of Health and Welfare (P01-202203-01-005) and performed in accordance with the principles of the Declaration of Helsinki.
Conflicts of Interest
Jong-Koo Lee has been the editor-in-chief of Osong Public Health and Research Perspectives since October 2021, but had no role in the decision to publish this article. No other potential conflict of interest relevant to this article has been declared.
Funding
This research was supported by a grant of the Korea Disease Control and Prevention Agency (No: 2021-05-008).
Availability of Data
The datasets are not publicly available. If you have any questions about this study, please contact the corresponding author (nchoi@ewha.ac.kr; bjpark@snu.ac.kr).
Authors’ Contributions
Conceptualization: NYJ, JKL, BJP, NKC; Methodology: NYJ, HP, SO, SEJ, DHK, HSS, JKL, HCH, JHW, BJP, NKC; Project administration: BJP; Visualization: NYJ; Writing–original draft: NYJ, NKC; Writing–review & editing: all authors. All authors read and approved the final manuscript.
Category | Adverse events of special interest | Schedule for announcement of results |
---|---|---|
Death | All-cause death | 2nd Forum (March 4, 2022) |
Cardio-cerebrovascular diseases | Myocarditis | 2nd Forum (March 4, 2022) |
Pericarditis | 2nd Forum (March 4, 2022), | |
3rd Forum (May 21, 2022) | ||
Stroke | 2nd Forum (March 4, 2022) | |
Acute myocardial infarction | 2nd Forum (March 4, 2022) | |
Heart failure | 3rd Forum (May 21, 2022) | |
Aortic dissection | 3rd Forum (May 21, 2022) | |
Neurological diseases | Acute transverse myelitis | 3rd Forum (May 21, 2022) |
Acute disseminated encephalomyelitis | 3rd Forum (May 21, 2022) | |
Guillain-Barré syndrome | 3rd Forum (May 21, 2022) | |
Miller–Fisher syndrome | 3rd Forum (May 21, 2022) | |
Obstetric diseases | Abnormal uterine bleeding | 4th Forum (August 11, 2022) |
Hematologic diseases | Deep vein thrombosis | 4th Forum (August 11, 2022) |
Pulmonary embolism | 4th Forum (August 11, 2022) | |
Cerebral venous sinus thrombosis | 4th Forum (August 11, 2022) |
Adverse events | Study results (statistical significance) | Utilization of research findings |
---|---|---|
All-cause death | Not significant | Not applicable |
Myocarditis | Significantly increased risk (only mRNA vaccines) | Acknowledged the causality of myocarditis that occurred after mRNA vaccination |
Pericarditis | Significantly increased risk (only mRNA vaccines) | Acknowledged the causality of pericarditis that occurred after mRNA vaccination |
Stroke | Not significant | Not applicable |
Acute myocardial infarction | Not significant | Not applicable |
Acute transverse myelitis | Significantly increased risk | Decided to perform a reanalysis |
Acute disseminated encephalomyelitis | Not significant | Decided to perform a reanalysis |
Heart failure | Not significant | Not applicable |
Aortic dissection | Not significant | Not applicable |
Abnormal uterine bleeding | Significantly increased risk | Added to the list of reportable adverse events following COVID-19 vaccination |
Deep vein thrombosis | Significantly increased risk (only BNT162b2 mRNA vaccines) | Decided to perform a reanalysis |
Pulmonary embolism | Significantly increased risk (only BNT162b2 mRNA vaccines) | Decided to perform a reanalysis |
Cerebral venous sinus thrombosis | Significantly increased risk | Identified the need to ensure the validity of diagnosis through electronic medical records research |
Guillain-Barré syndrome | Not significant | Decided to perform a reanalysis |
Miller–Fisher syndrome | Not significant | Decided to perform a reanalysis |