Abstract:

Objective To compare and analyze the reported incidence of adverse events following immunization（AEFI） following simultaneous vaccination with oral pentavalent rotavirus attenuated live vaccine（RV5） and 13-valent pneumococcal polysaccharide conjugate vaccine（PCV13） in Tianjin City，thereby improving the safety surveillance of multi-vaccine co-administration and providing a scientific basis for optimizing co-administration policies. Methods AEFI case data were exported from the AEFI monitoring module of the Immunization Program Subsystem of the China Disease Prevention and Control Information System according to the vaccination date. Concurrent relevant vaccination data were exported from the Tianjin Immunization Program Information Management System for analysis and comparison of reported incidence rates. Results From 2020 to 2024，the reported incidence rates of AEFIs in Tianjin were 18.23/100 000 doses for RV5 vaccination alone，104.51/100 000 doses for PCV13 vaccination alone，and 46.39/100 000 doses for simultaneous vaccination of RV5 and PCV13. The reported incidence rate of AEFI for simultaneous vaccination was lower than that for PCV13 vaccination alone（χ²=8.289，P<0.01），and higher than that for RV5 vaccination alone（χ²=7.530，P<0.01）. Conclusion The general reactions for single vaccination with PCV13，RV5，and simultaneous vaccination mainly diagnosed as symptoms of general reactions（fever/redness and swelling/hardening），while the abnormal reactions were mainly allergic reactions. Severe abnormal reactions were rare. The risk of simultaneous vaccination with PCV13 and RV5 did not increase，and the overall safety was good.

Key words: 13-valent pneumococcal polysaccharide conjugate vaccine, Oral pentavalent rotavirus attenuated live vaccine, Adverse event following immunization, Simultaneous vaccination