Post-marketing surveillance analysis of human papillomavirus vaccine safety in Hebei province from 2018 to 2022

ObjectiveTo analyze the characteristics of adverse events following immunization (AEFI) with human papillomavirus (HPV) vaccines in Hebei province from 2018 to 2022 and to evaluate the safety of these vaccines. MethodsAEFI cases following HPV vaccination in Hebei province from January 1, 2018, to December 31, 2022, were collected through the AEFI surveillance module of the Chinese Center for Disease Control and Prevention Information System. Descriptive analysis was conducted on the characteristics and reported incidence of AEFI. ResultsA total of 128 HPV vaccine AEFI cases were reported in Hebei province from 2018 to 2022, with an average annual reported incidence of 3.03/100 000 doses. The reported incidences of AEFI for the bivalent, quadrivalent, and 9-valent HPV vaccines (HPV2, HPV4, and HPV9, respectively) were 2.39/100 000 doses, 3.61/100 000 doses, and 3.38/100 000 doses, respectively. The AEFI reporting rate for HPV2 was lower than that for HPV4 (χ2=3.931, P<0.05). The reported incidences of general vaccine reactions for HPV2, HPV4, and HPV9 were 2.22/100 000 doses, 2.63/100 000 doses, and 2.74/100 000 doses, respectively. The reported incidences of local redness and swelling and fever were both higher than that of local induration (χ2=12.500, 5.918, both P<0.05). The reported incidences of rare reactions were 0.11/100 000 doses, 0.60/100 000 doses, and 0.55/100 000 doses for HPV2, HPV4, and HPV9, respectively. The incidence of vaccine reactions for both HPV4 and HPV9 were higher than that for HPV2 (χ2=5.763, 4.705, both P<0.05). All AEFI cases related to HPV vaccines recovered or improved, with a good overall outcome. ConclusionsThe reported incidences of AEFI for HPV vaccines in Hebei province were within acceptable limits, indicating good overall safety.