Real-world safety data of human papillomavirus vaccines after marketing in Shandong, China, August 2017–October 2025

After the Human papillomavirus (HPV) vaccine was listed for use in China in 2017, it has proven to be a safe and cost-effective method for preventing HPV infection. With the increase in vaccination volume, its safety is becoming increasingly important. The safety data from post-marketing can enhance public confidence in vaccines. We collected adverse events following immunization (AEFI) through the Chinese National AEFI Information Management System (CNAEFIs) between August 2017 and October 2025. Vaccination data from the same period were obtained via the Shandong Provincial Immunization Program Information Systems (SDIPIs). A Univariate Poisson regression model was used to explore risk factors associated with HPV vaccine AEFI. Disproportionality analysis was performed to detect abnormal signals related to the HPV vaccine. From August 2017 to October 2025 in Shandong, CNAEFIs received 1056 AEFI cases, with an overall reporting AEFI rate of 7.99 per 100,000 doses. 1008 cases (95.46%) were mild vaccine-related reactions, and 15 cases (1.42%) were rare adverse reactions. Myalgia, induration with a diameter greater than 5 cm, immune thrombocytopenia, and mild reactions such as fatigue, drowsiness, dizziness, and headache were detected as abnormal signals. The reporting AEFI rate of the HPV vaccine in Shandong was low, and the majority of AEFIs were mild cases. The safety profile in post-marketing was good.