Raethke Monika, Gorter Jeroen, Kalf Rachel, van Balveren Leontine, Jajou Rana, van Hunsel Florence
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands.
Department of PharmacoTherapy-Epidemiology & Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Broerstraat 5, 9712 CP Groningen, The Netherlands.
Vaccines (Basel). 2025 Jul 30;13(8):812. doi: 10.3390/vaccines13080812.
The aim of this study was to systematically assess Adverse Events Following Immunization (AEFI) among children following administration of the human papillomavirus (HPV) vaccine (Cervarix) included in the Dutch National Immunization Program (NIP) and to characterize the pattern and recurrence risk of AEFI after HPV revaccination. A longitudinal cohort event monitoring study, using patient-reported outcomes was used among recipients of the HPV vaccine at 10 years of age. Data were available for 3063 children following the first HPV vaccination and for 2209 children following the second HPV vaccination. The most commonly reported AEFI following HPV vaccination were injection site reactions-reported by 46.5% of participants after the first dose and 31.9% after the second dose-followed by headache (8.2% and 3.9%, respectively) and joint pain (4.5% and 3.7%, respectively). Participants who received both HPV vaccine doses reported more AEFI after the first dose than after the second. Among girls, 61.2% reported at least one AEFI following the first dose, compared to 44.2% after the second dose. For boys, these percentages were 55.3% and 38.5%, respectively. This difference was statistically significant ( = 0.002). For some AEFI, such as injection site reactions, there appears to be a potential increased risk of recurrence following the second dose. This prospective longitudinal cohort event monitoring study showed that AEFI were more frequent after the first HPV dose and more frequent for girls compared to boys. An increased risk of recurrence was seen for AEFI, such as injection site reactions and headache. Furthermore, this study provides insight into the course of AEFI and the extent to which children were affected by these symptoms based on real-world data.
本研究的目的是系统评估荷兰国家免疫规划（NIP）中包含的人乳头瘤病毒（HPV）疫苗（希瑞适）接种后儿童的免疫接种后不良事件（AEFI），并描述HPV再次接种后AEFI的模式和复发风险。在10岁的HPV疫苗接种者中进行了一项纵向队列事件监测研究，采用患者报告的结局。首次HPV疫苗接种后有3063名儿童的数据，第二次HPV疫苗接种后有2209名儿童的数据。HPV疫苗接种后最常报告的AEFI是注射部位反应——首次接种后46.5%的参与者报告有该反应，第二次接种后为31.9%——其次是头痛（分别为8.2%和3.9%）和关节痛（分别为4.5%和3.7%）。接受两剂HPV疫苗的参与者报告首次接种后出现的AEFI比第二次接种后更多。在女孩中，61.2%报告首次接种后至少出现一次AEFI，而第二次接种后为44.2%。对于男孩，这些百分比分别为55.3%和38.5%。这种差异具有统计学意义（=0.002）。对于某些AEFI，如注射部位反应，第二次接种后似乎有潜在的复发风险增加。这项前瞻性纵向队列事件监测研究表明，首次HPV接种后AEFI更频繁，女孩比男孩更常见。AEFI如注射部位反应和头痛的复发风险增加。此外，本研究基于实际数据深入了解了AEFI的病程以及儿童受这些症状影响的程度。
