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COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021
Insob Hwang, Kyeongeun Park, Tae Eun Kim, Yunhyung Kwon, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2021;12(6):396-402.   Published online December 21, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0310
  • 4,125 View
  • 154 Download
  • 7 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
Objectives
This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.
Methods
Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.
Results
By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.
Conclusion
The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.

Citations

Citations to this article as recorded by  
  • Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
    Nicoletta Luxi, Alexia Giovanazzi, Alessandra Arcolaci, Patrizia Bonadonna, Maria Angiola Crivellaro, Paola Maria Cutroneo, Carmen Ferrajolo, Fabiana Furci, Lucia Guidolin, Ugo Moretti, Elisa Olivieri, Giuliana Petrelli, Giovanna Zanoni, Gianenrico Senna,
    BioDrugs.2022; 36(4): 443.     CrossRef
  • Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea
    Seontae Kim, Insob Hwang, Mijeong Ko, Yunhyung Kwon, Yeon-Kyeng Lee
    Osong Public Health and Research Perspectives.2022; 13(3): 230.     CrossRef
  • Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme
    Laura Bonzano, Olivera Djuric, Pamela Mancuso, Lidia Fares, Raffaele Brancaccio, Marta Ottone, Eufemia Bisaccia, Massimo Vicentini, Alessia Cocconcelli, Alfonso Motolese, Rostyslav Boyko, Paolo Giorgi Rossi, Alberico Motolese
    Vaccines.2022; 10(7): 1111.     CrossRef
  • Global Predictors of COVID-19 Vaccine Hesitancy: A Systematic Review
    Carla Pires
    Vaccines.2022; 10(8): 1349.     CrossRef
  • Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review
    Pradipta Paul, Emmad Janjua, Mai AlSubaie, Vinutha Ramadorai, Beshr Mushannen, Ahamed Lazim Vattoth, Wafa Khan, Khalifa Bshesh, Areej Nauman, Ibrahim Mohammed, Imane Bouhali, Mohammed Khalid, Dalia Zakaria
    The Journal of Clinical Pharmacology.2022; 62(11): 1335.     CrossRef
  • Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
    Seontae Kim, Yeseul Heo, Soon-Young Seo, Do Sang Lim, Enhi Cho, Yeon-Kyeng Lee
    Osong Public Health and Research Perspectives.2022; 13(5): 382.     CrossRef
  • COVID-19 Vaccination in Korea: Past, Present, and the Way Forward
    Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021
Hyun-kyung Oh, Eun Kyeong Kim, Insob Hwang, Tae Eun Kim, Yeon-kyeong Lee, Eunju Lee, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2021;12(4):264-268.   Published online August 13, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0157
  • 3,496 View
  • 119 Download
  • 4 Citations
AbstractAbstract PDF
Objectives
On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods
Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results
In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion
By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.

Citations

Citations to this article as recorded by  
  • Safety and effectiveness of BNT162b2 mRNA Covid-19 vaccine in adolescents
    Young June Choe, Seonju Yi, Insob Hwang, Jia Kim, Young-Joon Park, Eunhee Cho, Myoungyoun Jo, Hyunju Lee, Eun Hwa Choi
    Vaccine.2022; 40(5): 691.     CrossRef
  • Direct and Indirect Associations of Media Use With COVID-19 Vaccine Hesitancy in South Korea: Cross-sectional Web-Based Survey
    Minjung Lee, Myoungsoon You
    Journal of Medical Internet Research.2022; 24(1): e32329.     CrossRef
  • Self-Reported COVID-19 Vaccines’ Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study
    Lama T AlMutairi, Wesal Y Alalayet, Sondus I Ata, Khalidah A Alenzi, Yazed AlRuthia
    Vaccines.2022; 10(6): 977.     CrossRef
  • COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021
    Insob Hwang, Kyeongeun Park, Tae Eun Kim, Yunhyung Kwon, Yeon-Kyeng Lee
    Osong Public Health and Research Perspectives.2021; 12(6): 396.     CrossRef

PHRP : Osong Public Health and Research Perspectives