Available online:March 17, 2026, DOI:
Abstract:
Abstract: Objective To explore the situation of HPV vaccine adverse reactions in Pudong New Area, Shanghai, from 2017 to 2024, and to provide scientific basis for the safety evaluation of HPV vaccine after marketing. Methods Data on suspected adverse events following immunization (AEFI) to HPV vaccines in Pudong New Area from 2017 to 2024 were collected to analyze the incidence of AEFI reports following HPV vaccination. Results From 2017 to 2024, a total of 1,436,659 doses of HPV vaccine were administered in Pudong New Area, with 1,610 AEFI cases reported. with an overall AEFI reporting rate of 112.07 per 100,000 doses administered. The respective numbers of reports for general reactions, abnormal reactions, psychogenic reactions, and coincidental events were 1,578 (109.84 per 100,000 doses), 24 (1.67 per 100,000 doses) , 5 cases (0.35 per 100,000 doses), and 3 cases (0.21 per 100,000 doses), respectively. The AEFI reports for bivalent, quadrivalent, and nonavalent HPV vaccines were 208 cases (193.30 per 100,000 doses administered), 457 cases (107.10 per 100,000 doses administered), and 945 cases (104.72 per 100,000 doses administered), respectively. During 2017-2024, the highest AEFI incidence rates for bivalent, quadrivalent, and nonavalent HPV vaccines were 530.50/100,000 doses, 190.56/100,000 doses, and 194.38/100,000 doses, respectively. Statistically significant differences in AEFI incidence rates were observed among different HPV vaccine types (P< 0.05). The number of AEFI reports for bivalent liquid penicillin, bivalent liquid pre-filled, quadrivalent liquid pre-filled, nonavalent liquid penicillin, and nonavalent liquid pre-filled vaccines were 53 cases (101.90 per 100,000 doses) , 155 cases (278.82 per 100,000 doses), 457 cases (107.10 per 100,000 doses), 41 cases (198.26 per 100,000 doses), and 904 cases (102.53 per 100,000 doses), respectively. The incidence rates of AEFI differed significantly among different dosage strengths of both the bivalent and nonavalent HPV vaccines (P < 0.05). The peak period for HPV vaccine-associated AEFI occurred within 0–0.5 days post-vaccination, with 854 cases (59.44/100,000 doses administered). The temporal distribution of AEFI varied significantly among different HPV vaccine types (P < 0.05) . The distribution of local redness and swelling as a common reaction differed significantly among HPV vaccine types (P<0.05). Conclusion: HPV vaccines exhibit a low incidence of adverse reactions, and post-vaccination adverse reaction monitoring should be strengthened. Conclusion HPV vaccine has a low incidence of AEFIs, and the monitoring of AEFIs after HPV vaccination should continue to be strengthened.