Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark.
Eur J Clin Pharmacol. 2011 Mar;67(3):283-8. doi: 10.1007/s00228-010-0944-9. Epub 2010 Nov 16.
There is no doubt that paediatric immunization prevents serious diseases, but the administration of these vaccines to healthy children also involves risks of adverse drug reactions (ADRs), some of which are potentially serious. The current body of evidence on ADRs from immunization therapy at the population level is partly contradictory across countries, time periods and childhood immunization programmes. The objective of our study was to characterize reported adverse events (AEFIs) following immunization in Danish children.
Adverse events (AEFIs) in 0- to 17-year-old children and adolescents reported to the Danish Medicines Agency (DKMA) between 1998 and 2007 were analysed. The unit of analysis was one AEFI. Data were categorized with respect to time, age, and gender of the children, suspected vaccines, category and seriousness of the AEFIs, and reporting rate.
During the study period, the DKMA received 1,365 reports covering 2,600 AEFIs, corresponding to 60% of all adverse events reported for children. One third of the AEFIs were classified as serious, and two deaths were reported. The annual number of serious AEFIs remained constant during the study period. Approximately 80% of AEFIs were reported in children aged 0-2 years. Of all reported AEs, 45% were in the category "general disorders and administration site conditions", followed by the categories "skin and subcutaneous tissue disorders" (20% of total AEFIs) and "nervous system disorders" (16% of total AEFIs). The largest share of serious events was from the category "nervous system disorders" (33% of serious AEFIs). The most frequently reported serious AEs were febrile convulsions, pyrexia, and injection-site reactions.
In Denmark, a large number of AEFIs following paediatric immunization have been reported, but the majority of cases were non-serious.
毫无疑问，儿科免疫接种可预防严重疾病，但向健康儿童接种这些疫苗也会带来药物不良反应 (ADR) 的风险，其中一些可能很严重。目前，关于人群水平免疫疗法的 ADR 证据在不同国家、时间段和儿童免疫接种方案之间存在部分矛盾。我们研究的目的是描述丹麦儿童接种疫苗后的不良事件 (AEFI)。
分析了 1998 年至 2007 年期间向丹麦药品管理局 (DKMA) 报告的 0-17 岁儿童和青少年的不良事件 (AEFI)。分析单位为一个 AEFI。根据儿童的时间、年龄和性别、可疑疫苗、AEFI 的类别和严重程度以及报告率对数据进行分类。
在研究期间，DKMA 收到了 1365 份报告，涉及 2600 个 AEFI，占儿童报告的所有不良事件的 60%。三分之一的 AEFI 被归类为严重，有两例死亡报告。研究期间严重 AEFI 的年数量保持不变。大约 80%的 AEFI 发生在 0-2 岁的儿童中。在所有报告的 AE 中，45%属于“一般疾病和注射部位状况”类别，其次是“皮肤和皮下组织疾病”（占总 AEFI 的 20%）和“神经系统疾病”（占总 AEFI 的 16%）。严重事件中最大的比例来自“神经系统疾病”类别（占严重 AEFI 的 33%）。报告的最常见严重 AE 是热性惊厥、发热和注射部位反应。
在丹麦，报告了大量的儿科免疫接种后不良事件，但大多数病例为非严重事件。
