Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Mail Stop D-26, 1600 Clifton Rd, Atlanta, GA 30333, USA.
Pediatrics. 2011 May;127 Suppl 1:S39-44. doi: 10.1542/peds.2010-1722G. Epub 2011 Apr 18.
On March 22, 2002, Internet-based reports (IBRs) were added to the Vaccine Adverse Event Reporting System (VAERS) to allow rapid, expedited reporting of adverse events (AEs) in anticipation of wider use of counter-bioterrorism vaccines such as those against smallpox and anthrax.
To evaluate the impact of IBRs on the timeliness and completeness of vaccine AE reporting.
To evaluate timeliness and completeness, we compared the proportions of IBRs with non-Internet-based reports (NIBRs). Report interval was analyzed for timeliness and age at vaccination, birth date, and onset date for report completeness. To evaluate the impact of the smallpox vaccination program, we compared smallpox vaccine reports separately. Because influenza vaccine is the most widely used vaccine in adults each year, we compared influenza vaccine reports separately.
During the study period, VAERS received 54 364 NIBRs (85.8%) and 9008 IBRs (14.2%). Sixteen percent (1455) of IBRs followed smallpox vaccination. Overall, for all vaccines and for smallpox vaccine alone, IBRs had a greater proportion of completeness and a shorter report interval. The proportion of most frequently reported AEs did not differ between IBRs and NIBRs. A higher proportion of adults (18-64 years old) who received influenza vaccine chose to complete an IBR (62% vs 48%).
The improved timeliness and completeness of IBRs allow VAERS to more rapidly detect new or rare vaccine AEs. This important advantage is critical in times of increased public concern about vaccine safety. Clinical vaccine providers should be aware of VAERS and use IBRs whenever feasible to report vaccine AEs.
2002 年 3 月 22 日,互联网报告(IBRs)被添加到疫苗不良事件报告系统(VAERS)中,以便在更广泛使用天花和炭疽等反恐疫苗之前,快速、加速报告不良事件(AEs)。
评估 IBRs 对疫苗 AE 报告及时性和完整性的影响。
为了评估及时性和完整性,我们比较了 IBRs 与非互联网报告(NIBRs)的比例。报告间隔用于分析及时性和疫苗接种年龄、出生日期和报告完整性的发病日期。为了评估天花疫苗接种计划的影响,我们分别比较了天花疫苗报告。由于流感疫苗是每年成人中使用最广泛的疫苗,我们也分别比较了流感疫苗报告。
在研究期间,VAERS 收到了 54364 份 NIBRs(85.8%)和 9008 份 IBRs(14.2%)。16%(1455)的 IBRs 是在接种天花疫苗之后。总体而言,对于所有疫苗和单独接种天花疫苗,IBRs 的完整性比例更高,报告间隔更短。IBRs 和 NIBRs 报告的最常见不良事件比例没有差异。接种流感疫苗的成年人(18-64 岁)中,选择完成 IBR 的比例更高(62%比 48%)。
IBRs 的及时性和完整性的提高使 VAERS 能够更快速地检测到新的或罕见的疫苗 AEs。在公众对疫苗安全性日益关注的时期,这一重要优势至关重要。临床疫苗提供者应了解 VAERS,并在可行的情况下使用 IBRs 报告疫苗 AEs。