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

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.