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

Abstract

Aim

To review current evidence regarding the occurrence, clinical presentation, and management of gastrointestinal adverse events following administration of RV1 and RV5 rotavirus vaccines in the paediatric population.

Methods

A systematic literature search was performed between April and August 2025. The review included randomised controlled trials, meta-analyses, and relevant case reports published from 2007 onwards. Primary outcomes focused on gastrointestinal manifestations: Prolongeddiarrhoea, intussusception, and immune-mediated diseases. Secondary outcomes included clinical management of GI post-vaccination events.

Results

Out of 197 identified studies, 86 met the inclusion criteria. Mild gastrointestinal symptoms, such as transient diarrhoea and vomiting, were common but typically self-limited. No increased risk of prolonged diarrhoea was identified in healthy infants, although rare cases were reported in children with severe immunodeficiencies. Data showed no increased risk of intussusception or immune-mediated conditions like celiac disease or inflammatory bowel disease. Specific high-risk groups, including infants with a history of intussusception, severe combined immunodeficiency, or metabolic disorders, were associated with a higher incidence of adverse events.

Conclusion

RV1 and RV5 vaccines maintain an excellent safety profile. In high-income settings, prolonged post-vaccination diarrhoea should be considered a clinical marker for underlying immunodeficiency rather than a risk factor for future immune-mediated intestinal disorders.