1COVID-19 Vaccine Safety Research Center, Seoul, Republic of Korea
2Department of Health Convergence, College of Science & Industry Convergence, Ewha Womans University, Seoul, Republic of Korea
3Department of Preventive Medicine, College of Medicine, Graduate Program in System Health Science & Engineering, Ewha Womans University, Seoul, Republic of Korea
4National Academy of Medicine of Korea, Seoul, Republic of Korea
5Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Republic of Korea
6Department of Radiology, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
7Department of Social and Preventive Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea
8Department of Infectious Diseases, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Republic of Korea
9Department of Physiology, Korea University College of Medicine, Seoul, Republic of Korea
10Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Republic of Korea
11Artificial Intelligence and Big-Data Convergence Center, Gil Medical Center, Gachon University, Incheon, Republic of Korea
12Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
13School of Pharmacy, Sungkyunkwan University, Suwon, Republic of Korea
14Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Republic of Korea
15Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea
16College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea
17Department of Global Innovative Drugs, The Graduate School of Chung-Ang University, Chung-Ang University, Seoul, Republic of Korea
18Graduate School of Industrial Pharmaceutical Science, College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea
© 2024 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 the 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 from the Korea Disease Control and Prevention Agency.
Authors’ Contributions
Conceptualization: NYJ, JKL, BJP, NKC; Methodology: all authors; Project administration: BJP; Visualization: NYJ; Writing–original draft: NYJ, NKC; Writing–review & editing: all authors. All authors read and approved the final manuscript.
Adverse events of interest | Announcement date | Epidemiological study results (statistical significance)a) | Causality assessment results | Policy Measures on the Association Between COVID-19 Vaccines and Adverse Events (vaccine type and time)b) |
---|---|---|---|---|
Death | ||||
All cause death | March 4, 2022 | NS | -d) | |
Cardio-cerebrovascular disease | ||||
Myocarditis | March 4, 2022 | Increased (only for mRNA vaccines) | Several criteria are mete) | BNT162b2 and mRNA-127; Mar 2022f) |
NVX-CoV2373; Dec 2022g) | ||||
Pericarditis | May 12, 2022c) | Increased (only for mRNA vaccines) | Several criteria are mete) | BNT162b2 and mRNA-1273; May 2022f) |
NVX-CoV2373; Dec 2022g) | ||||
Stroke | March 4, 2022 | NS | There are no criteria mete) | |
Acute myocardial infarction | March 4, 2022 | NS | There are no criteria mete) | |
Heart failure | May 12, 2022 | NS | Several criteria are mete) | |
Aortic dissection | May 12, 2022 | NS | Most criteria cannot be evaluatede) | |
Neurological disease | ||||
Acute transverse myelitis | January 31, 2023c) | Increased | FA | ChAdOx1 and Ad26·COV2·S; Mar 2022h) |
BNT162b2 and mRNA-1273; Feb 2023g) | ||||
Acute disseminated encephalomyelitis | January 31, 2023c) | Increased | I | ChAdOx1h) |
Guillain-Barré syndrome·Miller-Fisher syndrome | January 31, 2023c) | Decreased | FA (only for adenovirus vector vaccines) or I | ChAdOx1 and Ad26·COV2·Sh) |
Multiple sclerosis | February 28, 2023 | NS | I | |
Convulsion/seizures | May 25, 2023 | NS | I | |
Bell’s palsy/facial nerve disorder | May 25, 2023 | Increased | I | BNT162b2, mRNA-1273, and ChAdOx1h) |
Encephalitis/encephalopathy | June 21, 2023 | Increased | FA | |
Encephalomeningitis | June 21, 2023 | NS | I | |
Obstetric disease | ||||
Abnormal uterine bleeding | August 11, 2022 | Increased | Several criteria are mete) | All type of vaccines; Aug 2022g) |
Hematologic disease | ||||
Deep vein thrombosis | February 28, 2023c) | NS | I | |
Pulmonary embolism | February 28, 2023c) | NS | I | |
Cerebral venous sinus thrombosis | August 11, 2022 | Increased | Several criteria are mete) | ChAdOx1 and Ad26·COV2·Sh) |
Thrombosis with thrombocytopenia syndrome | June 21, 2023c) | Increased | CS | ChAdOx1 and Ad26·COV2·Si) |
Inflammatory disease | ||||
Herpes zoster | February 28, 2023 | Increased | I | |
Lymphadenitis | March 30, 2023 | Increased | CS or FA | All type of vaccinesi) |
Lupus | May 25, 2023 | NS | I | |
Respiratory disease | ||||
Acute respiratory distress syndrome | March 30, 2023 | Decreased | I | |
Interstitial pulmonary diseases | April 27, 2023 | Decreased | I | |
Infectious disease | ||||
Sepsis | April 27, 2023 | NS | FR | |
Allergic reaction | ||||
Anaphylaxis | April 27, 2023 | Increased | FA | All type of vaccinesi) |
Surveillance of adverse event reports | ||||
Overall adverse event reports | March 4, 2022; May 12, 2022; January 31, 2023; April 27, 2023 | - | -d) | |
Adverse event reports of abnormal uterine bleeding | March 30, 2023 | - | -d) |
NS, not significant; FA, favors acceptance of a causal relationship; CS, convincingly supports a causal relationship; FA, favors acceptance of a causal relationship; FR, favors rejection of a causal relationship; I, inadequate to accept or reject a causal relationship.
a) The terms “increased” and “decreased” refer to significantly increased and decreased risk, respectively.
b) This column indicates the timing of policy measures and whether the events were acknowledged as causally related or reportable, following vaccination with each type of COVID-19 vaccine. It also denotes whether the CoVaSC study results had an impact on these policy measures.
c) The outcome was re-analyzed, and only the date to release the results of final re-analysis was included.
d) Causality assessment was not conducted for the adverse event.
e) The Bradford Hill Criteria and the Surgeon General’s epidemiological criteria for causality were used for causal inference.
f) Acknowledgement of causality based on CoVaSC research findings.
g) Added to the list of reportable adverse events based on CoVaSC research findings.
h) Initially listed as reportable adverse events prior to CoVaSC findings.
i) Initially included in the list of adverse events already acknowledged to exhibit a causal relationship before the CoVaSC research.