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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 Res Perspect. 2022;13(3):230-237.   Published online June 10, 2022
DOI: https://doi.org/10.24171/j.phrp.2022.0122
  • 3,832 View
  • 136 Download
  • 6 Web of Science
  • 6 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Objectives
This study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea. Methods: Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed. Results: From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-yearolds were reported to the CVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia. Conclusion: The overall results are consistent with previous findings; the great majority of adverse events were non-serious, and serious adverse events were rare among adolescents aged 12 to 17 years following Pfizer-BioNTech COVID-19 vaccination.

Citations

Citations to this article as recorded by  
  • Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis
    Peng Gao, Liang-Yu Kang, Jue Liu, Min Liu
    World Journal of Pediatrics.2023; 19(11): 1041.     CrossRef
  • Incidence of myopericarditis after mRNA COVID-19 vaccination: A meta-analysis with focus on adolescents aged 12–17 years
    Bao-Qiang Guo, Hong-Bin Li, Li-Qiang Yang
    Vaccine.2023; 41(28): 4067.     CrossRef
  • Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
    Yeon-Kyeng Lee, Yunhyung Kwon, Yesul Heo, Eun Kyoung Kim, Seung Yun Kim, Hoon Cho, Seontae Kim, Mijeong Ko, Dosang Lim, Soon-Young Seo, Enhi Cho
    Clinical and Experimental Pediatrics.2023; 66(10): 415.     CrossRef
  • Risk of Coronavirus Disease 2019 Messenger RNA Vaccination-Associated Myocarditis and Pericarditis – A Systematic Review of Population-Based Data
    Yen-Ching Lin, Chia-Hsuin Chang, Wei-Ju Su, Chin-Hui Yang, Jann-Tay Wang
    Risk Management and Healthcare Policy.2023; Volume 16: 2085.     CrossRef
  • Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents
    Mi Jin Kim, Jin Hee Kim, Hyun Ok Jun, Kyung Min Kim, Min Sub Jeung, Jun Sung Park
    Journal of Pediatric Infectious Diseases.2023;[Epub]     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 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
  • 6,785 View
  • 190 Download
  • 13 Web of Science
  • 11 Crossref
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  
  • A Nationwide Survey of mRNA COVID-19 Vaccinee’s Experiences on Adverse Events and Its Associated Factors
    Dongwon Yoon, Ha-Lim Jeon, Yunha Noh, Young June Choe, Seung-Ah Choe, Jaehun Jung, Ju-Young Shin
    Journal of Korean Medical Science.2023;[Epub]     CrossRef
  • Temporal association between the age-specific incidence of Guillain-Barré syndrome and SARS-CoV-2 vaccination in Republic of Korea: a nationwide time-series correlation study
    Hyunju Lee, Donghyok Kwon, Seoncheol Park, Seung Ri Park, Darda Chung, Jongmok Ha
    Osong Public Health and Research Perspectives.2023; 14(3): 224.     CrossRef
  • Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
    Yeon-Kyeng Lee, Yunhyung Kwon, Yesul Heo, Eun Kyoung Kim, Seung Yun Kim, Hoon Cho, Seontae Kim, Mijeong Ko, Dosang Lim, Soon-Young Seo, Enhi Cho
    Clinical and Experimental Pediatrics.2023; 66(10): 415.     CrossRef
  • 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
  • Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea
    Yunhyung Kwon, Insob Hwang, Mijeong Ko, Hyungjun Kim, Seontae Kim, Soon-Young Seo, Enhi Cho, Yeon-Kyeng Lee
    Epidemiology and Health.2022; 45: e2023006.     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
  • 5,639 View
  • 141 Download
  • 7 Web of Science
  • 6 Crossref
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  
  • A prospective cohort study protocol: monitoring and surveillance of adverse events following heterologous booster doses of Oxford AstraZeneca COVID-19 vaccine in previous recipients of two doses of Sinopharm or Sputnik V vaccines in Iran
    Shahin Soltani, Behzad Karami Matin, Mohammad Mehdi Gouya, Sayed Mohsen Zahraei, Ghobad Moradi, Omid Chehri, Moslem Soofi, Mehdi Moradinazar, Fatemeh Khosravi Shadmani, Mahsa Kalantari, Hamidreza Khajeha, Mohammad Hassan Emamian, Farid Najafi
    BMC Public Health.2023;[Epub]     CrossRef
  • Herpes Zoster Reactivation After mRNA and Adenovirus-Vectored Coronavirus Disease 2019 Vaccination: Analysis of National Health Insurance Database
    Jin Gu Yoon, Young-Eun Kim, Min Joo Choi, Won Suk Choi, Yu Bin Seo, Jaehun Jung, Hak-Jun Hyun, Hye Seong, Eliel Nham, Ji Yun Noh, Joon Young Song, Woo Joo Kim, Dong Wook Kim, Hee Jin Cheong
    The Journal of Infectious Diseases.2023; 228(10): 1326.     CrossRef
  • 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