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
Anaphylaxis post-COVID-19 vaccinations in Singapore Li Fung Peck, Wang Woon Poh, Adena Theen Lim, Sally Bee Leng Soh, Mun Yee Tham, Belinda Pei Qin Foo, Amelia Jing Jing Ng, Patricia Suet Ling Ng, Pei San Ang, Cheng Leng Chan, Dorothy Su Lin Toh, Edmund Jon Deoon Lee, Amelia Santosa, Bernard Yu-Hor Thong, Singapore Medical Journal.2024;[Epub] CrossRef
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
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