Evidence map›Paper›PMID 37309116›Full record

ArticleClinical and experimental pediatrics2023

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 and 1 more

Abstract read
In one paragraph

Article in Clinical and experimental pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yeon-Kyeng LeeAdverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Yunhyung KwonAdverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Yesul HeoAdverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Eun Kyoung KimAdverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Seung Yun KimAdverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Hoon ChoAdverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Seontae KimAdverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Mijeong KoAdverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Dosang LimAdverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Soon-Young SeoAdverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
Enhi ChoImmunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 Prevention Agency has enhanced vaccine safety monitoring through a passive web-based reporting system and active text message-based 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 the 5 COVID-19 vaccine brands were analyzed. AE reports from the web-based COVID-19 Vaccination Management System and text message-based reports from recipients were analyzed. AEs were classified as nonserious or serious (e.g., death or anaphylaxis). The AE reporting rates were calculated based on the number of COVID-19 vaccine doses administered. A total of 125,107,883 doses were administered in Korea from February 26, 2021, to June 4, 2022. Among them, 471,068 AEs were reported, of which 96.1% were nonserious and 3.9% were serious. Among the 72,609 participants in the text message-based AE monitoring process, a higher AE rate of local and systemic reactions was reported for the 3rd versus 1st doses. A total of 874 cases of anaphylaxis (7.0 per 1,000,000 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 with COVID-19 vaccination (1 of TTS and 5 of myocarditis). Young adult age and female sex were related with a higher AE rate for COVID-19 vaccines. Most reported AEs were nonserious and of mild intensity.

Indexed as

Adverse reactionsCOVID-19PharmacovigilanceSafetyVaccination

Identifiers

PMID37309116
PMCPMC10556797

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.