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J Health Info Stat > Volume 49(2); 2024 > Article
J Health Info Stat 2024;49(2):160-168.
Published online: May 31, 2024.
DOI: https://doi.org/10.21032/jhis.2024.49.2.160

국내 코로나19백신 안전성 모니터링을 위한 특별관심이상사례 배경발생률
김정아1 , 원희현2 , 임은선2 , 최남경3
1이화여자대학교 융합보건학과 석박통합과정생
2이화여자대학교 융합보건학과 박사과정생
3이화여자대학교 융합보건학과 & 제약산업학과 교수
Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring in South Korea
Jeong Ah Kim1 , Heehyun Won2 , Eunsun Lim2 , Nam-Kyong Choi3
1Combined Master-Doctoral Student, Department of Health Convergence, Ewha Womans University, Seoul, Korea
2Doctoral Student, Department of Health Convergence, Ewha Womans University, Seoul, Korea
3Professor, Department of Health Convergence & Department of Industrial Pharmaceutical Science, Ewha Womans University, Seoul, Korea
Corresponding author:  Nam-Kyong Choi,Tel: +82-2-3277-6585, Email: nchoi@ewha.ac.kr
Received: March 13, 2024; Revised: May 9, 2024   Accepted: May 31, 2024.
ABSTRACT
Objectives:
This study aimed to estimate background incidence rates (IR) for adverse events of special interest (AESI) associated with COVID-19 vaccines in South Korea.
Methods:
We used data from the Korean National Health Insurance Service-National Sample Cohort from January 1, 2015 to December 31, 2019, with IR calculated annually. Eight AESIs including acute myocarditis, acute pericarditis, acute disseminated encephalomyelitis (ADEM), acute transverse myelitis (ATM), encephalitis, anaphylaxis, Bell’s palsy, and lymphadenitis were evaluated. Two operational strategies were implemented: a broad definition using ICD-10 codes for primary or secondary diagnoses to enhance sensitivity, and a narrow definition integrating ICD-10 codes with procedure and drug codes for enhanced accuracy and specificity. IR was calculated by dividing the number of incident cases by the total person-time at risk, with separate analyses by sex and age.
Results:
During the study period, the incidence of anaphylaxis, Bell’s palsy, and lymphadenitis under the broad definition continued to increase. Under the narrow definition, there were no reported cases of acute myocarditis or Bell’s palsy from 2015 to 2019. Additionally, the incidence rates for acute pericarditis, ADEM, ATM, encephalitis, anaphylaxis, and lymphadenitis were lower than those calculated under the broad definition. Males generally had higher rates, except for Bell’s palsy and lymphadenitis. Most AESIs were more common in individuals aged 65 and older, whereas ADEM and lymphadenitis were higher in children aged 0-19 years.
Conclusions:
Variability in AESI rates emphasizes the importance of considering definitions and demographics when establishing background rates for surveillance, which is a critical aspect of monitoring vaccine safety.
Key words: COVID-19, Vaccination, Adverse event
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