Real-world study: Analysis of post-marketing safety for recombinant zoster vaccine in Shandong, China.

This study evaluated the safety of the recombinant zoster vaccine (RZV) after its marketing in Shandong, China, using adverse events following immunization (AEFI) data. AEFI reports for RZV were collected by the Chinese National AEFI Information Management System (CNAEFIs) between July 2020 and September 2024. In total, 279 AEFI cases were found after administering 145,865 doses of RZV, resulting in an AEFI rate of 19.13 per 10,000 doses. Of these cases, 274 (98.21%) were attributed to vaccine-related reactions, while 5 (1.79%) were coincidental events. The reporting rate was higher for the first dose (24.22 per 10,000) than that for the second (13.20 per 10,000), and the reporting rate was higher in females (21.71 per 10,000) than in males (14.31 per 10,000). Fever, localized redness/induration accounted for 92.83% of the cases after administering RZV. Three positive signals, zoster, vestibular neuritis, and moderate fever, were detected using data mining. No new adverse reactions were identified, and 97.49% of AEFI cases were mild, indicating that the post-marketing safety profile of RZV remains within the expected limit.