Evidence map›Paper›PMID 41305793›Full record

Observational studyMedicine2025

Global epidemiology of vaccine-associated intussusception in children and adolescents, 1968 to 2024: An international pharmacovigilance study.

Tae Hyeong Kim, Hyesu Jo, Damiano Pizzol, Lee Smith, Dong Keon Yon

Abstract readObservational Study
In one paragraph

Observational study in Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Tae Hyeong KimDepartment of Pediatrics, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.
Hyesu JoCenter for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea.
Damiano PizzolHealth Unit Eni, Maputo, Mozambique.
Lee SmithCentre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK.
Dong Keon YonCenter for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea.ORCID 0000-0003-1628-9948

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rotavirus vaccine associated intussusception has been investigated to some extent, limited research exists on intussusception caused by all vaccines from a comprehensive, global perspective. Thus, this study aimed to investigate the global burden of vaccine-associated intussusception using a comprehensive pharmacovigilance database. This study was conducted using data from the global pharmacovigilance database from 1968 to 2024. Reports of intussusception were identified by MedDRA code and categorized by vaccine type, age, sex, and region. Statistical disproportionality analysis was performed using reporting odds ratios (ROR) with 95% confidence interval (CI) and information components (IC) with IC025 to assess vaccine-specific signal detections. Among 35 million vaccine-associated total adverse events, 12,055 reports of vaccine-associated intussusception were identified. Rotavirus vaccines exhibited the strongest signal detections with intussusception (ROR, 70.16 [95% CI, 67.56-72.86]; IC, 5.27 [IC025, 5.22]), followed by diphtheria, tetanus, acellular pertussis, polio, and Haemophilus influenzae type b (ROR, 3.82 [95% CI, 3.67-3.97]; IC, 1.55 [IC025, 1.49]) and pneumococcal vaccines (ROR, 8.54 [95% CI, 8.13-8.96]; IC, 2.84 [IC025, 2.77]). The mean time to onset was 2.77 days, with a low fatality rate (0.07%). While our findings do not allow for causal conclusions, the results of this study suggest that rotavirus vaccines may be associated with a slight increase in the risk of intussusception. However, it is important to note that their benefits in preventing severe diarrheal disease far outweigh the risks.

Indexed as

IntussusceptionPharmacovigilanceRotavirus VaccinesVaccinesAdolescentAdverse Drug Reaction Reporting SystemsChildChild, PreschoolDatabases, FactualFemaleGlobal HealthHumansInfantMaleRotavirus VaccinesVaccinesepidemiologyvaccinevaccine-associated intussusception

Identifiers

PMID41305793
PMCPMC12643591

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LicenceCC BY
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Registered trials

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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.