Objective To analyze the safety of simultaneous vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) and oral pentavalent human rotavirus live attenuated vaccine (RV5) in age-eligible children in Changning District, Shanghai.

Methods Adverse events following immunization (AEFI) and vaccination information after PCV13 and RV5 vaccination from Jan.1, 2022 to Dec.31, 2023 were collected through the National Immunization Program Information Management System and the Shanghai Immunization Information System in Changning District. We compared the incidence rates of AEFI reports after PCV13 and RV5 standalone and simultaneous vaccination.

Results PCV13 was administered standalone in 7 654 doses, with 107 AEFI reports and an AEFI reporting rate of 1 397.96/100 000, including 1 371.83/ 100 000 for general reactions (105 cases) and 26.13/100 000 for abnormal reactions (2 cases). RV5 was administered standalone in 8 114 doses, with 30 AEFI reports and an AEFI reporting rate of 369.73/100 000, all of which were general reactions. PCV13 and RV5 were administered simultaneously in 6 731 doses, with 56 AEFI reports and an AEFI reporting rate of 831.97/100 000, including 802.26/100 000 for general reactions (54 cases), 14.86/100 000 for abnormal reactions (1 case), and 14.86/100 000 for coupling symptoms (1 case).

Conclusion The incidence rates of AEFI reports after PCV13 and RV5 vaccination standalone or simultaneous among age-eligible children in Changning District are within an acceptable range, primarily consisting of general reactions. PCV13 and RV5 simultaneous vaccination did not increase the risk of AEFI incidence.