To analyze the characteristics of Adverse Events Following Immunization (AEFI) of domestic rotavirus (live) vaccine (RVVO) in Shaanxi province from 2018 to 2022, and to evaluate the safety of RVVO vaccination.

The AEFI case data on RVVO vaccination in Shaanxi Province between 2018 and 2022 was gathered from the China AEFI Information Management System., and the vaccination situation of RVVO in Shaanxi province was collected through the immunization planning information management system of Shaanxi province. The analysis was conducted using the descriptive epidemiological technique.

A total of 461 102 doses of RVVO were inoculated in Shaanxi province from 2018 to 2022, and 48 cases of AEFI were recorded, with an incidence of 10.41 cases per 100 000 doses, including 43 cases of normal reactions (9.33 cases per 100 000 doses) and 3 cases of abnormal reactions (0.65 cases per 100 000 doses). 2 cases of coupling disease and No serious AEFI cases recorded. The three abnormal reactions were allergic rash (0.22/100 000 doses), acute diarrhea (0.22/100 000 doses) and rotavirus diarrhea (0.22/100 000 doses). 97.92% of the reported AEFI cases were cured or improved after follow-up, and no sequelae and death cases were reported. The age of onset of AEFI was less than 1 year old and occurred on the day of inoculation. The incidence of AEFI at the first, second and third doses was 12.65 cases per 100 000 doses, 10.64 cases per 100,000 doses and 361 cases per 100 000 doses, respectively. RVVO combined with other vaccines reported a general reaction rate of 10.16 per 100 000 doses and an abnormal reaction rate of 0.97 per 100 000 doses in AEFI.

The domestic oral live attenuated rotavirus vaccine has good safety, and the timely vaccination rate of children should be further strengthened.