Evidence map›Paper›PMID 38442719›Full record

ArticleJournal of Korean medical science2024

Adverse Events Following COVID-19 Vaccination in Adolescents: Insights From Pharmacovigilance Study of VigiBase.

Dong Hyuk Kim, Ju Hwan Kim, In-Sun Oh, Young June Choe, Seung-Ah Choe, Ju-Young Shin

Open access · goldAbstract read
In one paragraph

Article in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.1field-weighted citation impact, top 9% of its field
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

6 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Dong Hyuk Kim *Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0009-0009-5425-2143
Ju Hwan Kim *Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0001-7253-6515
In-Sun OhSchool of Pharmacy, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0001-9878-4779
Young June ChoeDeparment of Pediatrics, Korea University Anam Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0003-2733-0715
Seung-Ah ChoeDeparment of Preventive Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-6270-5020
Ju-Young ShinDepartment of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0003-1010-7525
Korea University · JPSungkyunkwan University · KRJewish General Hospital · CASamsung (South Korea) · KR

Funding

Ministry of EducationMinistry of Food and Drug Safety 21153MFDS607Ministry of Food and Drug Safety 22183MFDS433National Research Foundation of Korea
6 · The paper itself

Abstract

backgroundDuring coronavirus disease 2019 (COVID-19) pandemic, several COVID-19 vaccines were licensed with fast-track procedures. Although these vaccines have demonstrated high immunogenicity, there has been concerns on the serious adverse events (AEs) following COVID-19 vaccination among adolescents. We aimed to analyze comparative safety of COVID-19 vaccination in adolescents.

methodsIn this pharmacovigilance study, we performed a disproportionality analysis using VigiBase, the World Health Organization's global individual case safety report (ICSR) database. To compare serious AEs reported following COVID-19 vaccines vs. all other vaccines in adolescents aged 12-17 years, ICSRs following any vaccines on adolescents aged 12-17 years were included, defining cases as reports with the AEs of interest, with all other AEs as non-cases. The AEs of interest were myocarditis/pericarditis, multisystem inflammatory syndrome/Kawasaki disease (MIS/KD), anaphylaxis, Guillain-Barré syndrome (GBS), and immune thrombocytopenia (ITP). We conducted a disproportionality analysis to estimate reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE of interest, adjusted for sex by using logistic regression.

resultsOf 99,735 AE reports after vaccination in adolescents, 80,018 reports were from COVID-19 vaccinated adolescents (52.9% females; 56.3% America). The AEs of interest were predominantly reported as serious AE (76.1%) with mRNA vaccines (99.4%). Generally, higher reporting odds for the AEs were identified following COVID-19 vaccination in adolescents; myocarditis/pericarditis (2,829 reports for the COVID-19 vaccine vs. 35 for all other vaccines, adjusted ROR [aROR], 19.61; 95% CI, 14.05-27.39), and MIS/KD (104 vs. 6, aROR, 4.33; 95% CI, 1.89-9.88). The reporting odds for anaphylaxis (515 vs. 165, aROR, 0.86; 95% CI, 0.72-1.02), GBS (94 vs. 40, aROR, 0.64; 95% CI, 0.44-0.92) and ITP (52 vs. 12, aROR, 1.12; 95% CI, 0.59-2.09) were not significantly higher following COVID-19 vaccination.

conclusionIn this study, there were disproportionate reporting of immune-related AEs following COVID-19 vaccination. While awaiting definitive evidence, there is a need to closely monitor for any signs of immune-related AEs following COVID-19 vaccination among adolescents.

Indexed as

AnaphylaxisCOVID-19COVID-19 VaccinesGuillain-Barre SyndromeMucocutaneous Lymph Node SyndromeMyocarditisPericarditisPurpura, Thrombocytopenic, IdiopathicAdolescentFemaleHumansMalePharmacovigilanceVaccinationCOVID-19 VaccinesAdolescentsAdverse EventsCOVID-19 VaccineDisproportionality Analysis

Identifiers

PMID38442719
PMCPMC10911943
OpenAlexW4391827555

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.