Hibbs Beth F, Moro Pedro L, Lewis Paige, Miller Elaine R, Shimabukuro Tom T
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, MS D-26 Atlanta, GA, USA.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, MS D-26 Atlanta, GA, USA.
Vaccine. 2015 Jun 22;33(28):3171-8. doi: 10.1016/j.vaccine.2015.05.006. Epub 2015 May 14.
Vaccination errors are preventable events. Errors can have impacts including inadequate immunological protection, possible injury, cost, inconvenience, and reduced confidence in the healthcare delivery system.
To describe vaccination error reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and identify opportunities for prevention.
We conducted descriptive analyses using data from VAERS, the U.S. spontaneous surveillance system for adverse events following immunization. The VAERS database was searched from 2000 through 2013 for U.S. reports describing vaccination errors and reports were categorized into 11 error groups. We analyzed numbers and types of vaccination error reports, vaccines involved, reporting trends over time, and descriptions of errors for selected reports.
We identified 20,585 vaccination error reports documenting 21,843 errors. Annual reports increased from 10 in 2000 to 4324 in 2013. The most common error group was "Inappropriate Schedule" (5947; 27%); human papillomavirus (quadrivalent) (1516) and rotavirus (880) vaccines were most frequently involved. "Storage and Dispensing" errors (4983; 23%) included mostly expired vaccine administered (2746) and incorrect storage of vaccine (2202). "Wrong Vaccine Administered" errors (3372; 15%) included mix-ups between vaccines with similar antigens such as varicella/herpes zoster (shingles), DTaP/Tdap, and pneumococcal conjugate/polysaccharide. For error reports with an adverse health event (5204; 25% of total), 92% were classified as non-serious. We also identified 936 vaccination error clusters (i.e., same error, multiple patients, in a common setting) involving over 6141 patients. The most common error in clusters was incorrect storage of vaccine (582 clusters and more than 1715 patients).
Vaccination error reports to VAERS have increased substantially. Contributing factors might include changes in reporting practices, increasing complexity of the immunization schedule, availability of products with similar sounding names or acronyms, and increased attention to storage and temperature lapses. Prevention strategies should be considered.
疫苗接种错误是可预防的事件。这些错误可能产生多种影响，包括免疫保护不足、可能的伤害、成本增加、不便以及对医疗保健提供系统信心的降低。
描述提交给疫苗不良事件报告系统（VAERS）的疫苗接种错误报告，并确定预防机会。
我们使用来自VAERS（美国免疫接种后不良事件自发监测系统）的数据进行描述性分析。在2000年至2013年期间搜索VAERS数据库，查找描述疫苗接种错误的美国报告，并将报告分为11个错误类别。我们分析了疫苗接种错误报告的数量和类型、涉及的疫苗、随时间的报告趋势以及选定报告的错误描述。
我们识别出20585份记录了21843起错误的疫苗接种错误报告。年度报告从2000年的10份增加到2013年的4324份。最常见的错误类别是“接种计划不当”（5947起；27%）；人乳头瘤病毒（四价）疫苗（1516起）和轮状病毒疫苗（880起）涉及最为频繁。“储存与分发”错误（4983起；23%）主要包括接种过期疫苗（2746起）和疫苗储存不当（2202起）。“接种错误疫苗”错误（3372起；15%）包括具有相似抗原的疫苗之间的混淆，如水痘/带状疱疹（带状疱疹）、白百破/破伤风类毒素无细胞百白破以及肺炎球菌结合疫苗/多糖疫苗。对于伴有不良健康事件的错误报告（5204起；占总数的25%），92%被归类为非严重事件。我们还识别出936起疫苗接种错误聚集事件（即同一错误在同一环境中涉及多名患者），涉及超过6141名患者。聚集事件中最常见的错误是疫苗储存不当（582起聚集事件，超过1715名患者）。
向VAERS报告的疫苗接种错误大幅增加。促成因素可能包括报告方式的变化、免疫接种计划日益复杂、名称或首字母缩写相似的产品的可用性以及对储存和温度失误的关注度增加。应考虑预防策略。
