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Gastrointestinal Adverse Events Following Rotavirus Vaccination in Children: A Systematic Review

Francesca Musto1, Antonio Corsello2,3, Sara Curto4

  • 1Pediatric Gastroenterology, Hepatology and Cystic Fibrosis Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy.

Acta Paediatrica (Oslo, Norway : 1992)
|August 1, 2026
PubMed

Insights

Rotavirus vaccines RV1 and RV5 show an excellent safety profile in children. Prolonged diarrhea post-vaccination may indicate immunodeficiency, not a risk for future intestinal issues.

Area of Science:

  • Pediatric Gastroenterology
  • Vaccine Safety Research
  • Immunology

Background:

  • Rotavirus vaccines (RV1 and RV5) are crucial for preventing severe rotavirus gastroenteritis in children.
  • Gastrointestinal adverse events are a concern following vaccination, necessitating a review of current evidence.
  • Understanding these events is vital for maintaining public trust and vaccine uptake.

Purpose of the Study:

  • To comprehensively review the occurrence, clinical presentation, and management of gastrointestinal adverse events after RV1 and RV5 rotavirus vaccine administration in pediatric populations.
  • To assess the safety profile of rotavirus vaccines concerning specific gastrointestinal manifestations.

Main Methods:

  • Systematic literature search conducted from April to August 2025, including RCTs, meta-analyses, and case reports from 2007 onwards.
  • Primary outcomes focused on prolonged diarrhea, intussusception, and immune-mediated diseases post-vaccination.
  • Secondary outcomes examined clinical management strategies for post-vaccination gastrointestinal events.

Main Results:

  • Out of 197 studies, 86 met inclusion criteria; mild, self-limiting GI symptoms were common.
  • No increased risk of prolonged diarrhea in healthy infants; rare cases noted in severe immunodeficiencies.
  • No increased risk of intussusception or immune-mediated diseases (celiac, IBD) observed.
  • High-risk groups (history of intussusception, SCID, metabolic disorders) showed higher adverse event incidence.

Conclusions:

  • Rotavirus vaccines RV1 and RV5 demonstrate an excellent safety profile in pediatric populations.
  • In high-income settings, prolonged post-vaccination diarrhea should prompt investigation for underlying immunodeficiency.
  • These findings reinforce the favorable risk-benefit ratio of rotavirus vaccination.
Abstract

Keywords:
RV1RV5gastrointestinal side effectsrotavirus vaccination

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