Monitoring Of Adverse Events In Rotavirus Vaccine Administration: A Single Center Experience

OBJECTIVE: This study aims to assess the adverse events following rotavirus vaccination, which is a major cause of preventable hospitalizations in early childhood. MATERIAL AND METHODS: At Gazi University Faculty of Medicine Hospital, rotavirus vaccination is recommended for all immunocompetent children in the social pediatrics clinic. This study included healthy infants who received a rotavirus vaccine between June 1, 2020, and December 31, 2022. Unforunately rotavirus vaccines are still not included in the national immunization program in Türkiye. The decision on vaccination and vaccine type was made together with families, based on information regarding doses, cost, and efficacy. Patients were monitored daily for one week after each dose of vaccination and contacted six months after the completion of the vaccination series. RESULTS: During the study period, 107 healthy infants (mean age: 4.1 months) received the rotavirus vaccine. Of these, 11 received RotaTeq® and 96 received Rotarix®. Adverse events occurred in 4 infants (3.7%). Among those vaccinated with Rotarix®, one experienced transient vomiting and diarrhea (increased frequency of defecation), another had intermittent bloody stools for one week, and a third had a single episode of bloody stool. One infant vaccinated with RotaTeq® experienced 2 episodes of non-bloody, watery diarrhea. All symptoms occurred after the first dose, resolving without additional treatment or hospitalization. No adverse events previously reported in the literature, such as fever, intussusception, irritability, seizures, apnea, bloating, bronchospasm, nasopharyngitis, bronchiolitis, Kawasaki disease, allergic reactions, or immune thrombocytopenic purpura, were observed following vaccination. CONCLUSION: In conclusion, consisted with existing literature, this study confirms that rotavirus vaccines are well tolerated and safe during infancy. Vaccination has the potential to reduce hospitalization rates, prevent complications associated with rotavirus infection, enhance protection against rotavirus disease. The rotavirus vaccine should be recommended for all infants without contraindications, and parents should be thoroughly informed of its benefits and safety.