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      • KCI등재

        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 질병관리본부 2022 Osong Public Health and Research Persptectives Vol.13 No.5

        Objectives: This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea.Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed.Results: A total of 14,786 adverse events among 5- to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5- to 11-year-old children (64.5 per 100,000 doses) than in 12- to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5- to 11-year-old children than in 12- to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness.Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5- to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.

      • KCI등재

        Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea

        Kwon Yunhyung,황인섭,고미정,김형준,Kim Seontae,Seo Soon-Young,Cho Enhi,Yeon-Kyeng Lee 한국역학회 2023 Epidemiology and Health Vol.45 No.-

        OBJECTIVES In Korea, a national coronavirus disease 2019 (COVID-19) vaccination program was implemented, including 4 vaccines against COVID-19. A text messaging-based survey, in addition to a passive adverse event reporting system, was launched to quickly report unusual symptoms post-vaccination. This study compared the frequency of adverse events after COVID-19 vaccination based on the vaccine type and the type of 2-dose regimen (homologous or heterologous). METHODS Self-reported adverse events were collected through a text-message survey for 7 days after each vaccination. This study included 50,950 vaccine recipients who responded to the survey at least once. Informed consent to receive surveys via text was obtained from the vaccine recipients on the date of first vaccination. RESULTS The recipients of mRNA vaccines reported local and systemic reactions 1.6 times to 2.8 times more frequently after dose 2 than after dose 1 (p<0.001), whereas ChAdOx1-S recipients reported significantly fewer local and systemic reactions after dose 2 than after dose 1 (p<0.001). Local and systemic reactions were approximately 2 times and 4 times more frequent for heterologous vaccination than for BNT162b2/BNT162b2 and ChAdOx1-S/ChAdOx1-S regimens, respectively. Young individuals, female, and those receiving heterologous vaccine regimens including ChAdOx1-S/BNT162b2 vaccines reported more adverse events than older participants, male, and those with homologous vaccine regimens. CONCLUSIONS Although a heterologous regimen, youth, and female sex were associated with a higher risk of adverse reactions after COVID-19 vaccination, no critical issues were noted. Active consideration of heterologous schedules based on the evidence of efficacy and safety appears desirable.

      • KCI등재

        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,Do Sang Lim,Soon-Young Seo,Enhi Cho 대한소아청소년과학회 2023 Clinical and Experimental Pediatrics (CEP) Vol.66 No.10

        As of June 2022, 5 coronavirus disease 2019 (COVID-19)vaccine brands have been used in Korea’s national immunization program. The Korea Disease Control and PreventionAgency has enhanced vaccine safety monitoring through apassive web-based reporting system and active text messagebased monitoring. In this study, an enhanced safety monitoring system for COVID-19 vaccines is described and the frequencies and types of adverse events (AEs) associated with the5 COVID-19 vaccine brands were analyzed. AE reports fromthe web-based COVID-19 Vaccination Management Systemand text message-based reports from recipients were analyzed. AEs were classified as nonserious or serious (e.g., death oranaphylaxis). The AE reporting rates were calculated basedon the number of COVID-19 vaccine doses administered. Atotal of 125,107,883 doses were administered in Korea fromFebruary 26, 2021, to June 4, 2022. Among them, 471,068AEs were reported, of which 96.1% were nonserious and3.9% were serious. Among the 72,609 participants in thetext message-based AE monitoring process, a higher AErate of local and systemic reactions was reported for the 3rdversus 1st doses. A total of 874 cases of anaphylaxis (7.0 per1,000,000 doses), 4 cases of thrombocytopenia syndrome(TTS), 511 cases of myocarditis (4.1 per 1,000,000 doses),and 210 cases of pericarditis (1.7 per 1,000,000 doses)were confirmed. Six fatalities were causally associated withCOVID-19 vaccination (1 of TTS and 5 of myocarditis). Young adult age and female sex were related with a higherAE rate for COVID-19 vaccines. Most reported AEs werenonserious and of mild intensity.

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