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2003年至2013年向疫苗不良事件报告系统(VAERS)报告的成人麻疹、腮腺炎和风疹疫苗接种后的不良事件。

Adverse Events Following Measles, Mumps, and Rubella Vaccine in Adults Reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013.

作者信息

Sukumaran Lakshmi, McNeil Michael M, Moro Pedro L, Lewis Paige W, Winiecki Scott K, Shimabukuro Tom T

机构信息

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention Emory University School of Medicine, Atlanta, Georgia.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention.

出版信息

Clin Infect Dis. 2015 May 15;60(10):e58-65. doi: 10.1093/cid/civ061. Epub 2015 Jan 30.

Abstract

BACKGROUND

Limited data exist on the safety of the measles, mumps, and rubella (MMR) vaccine in adults. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in this previously understudied group.

METHODS

VAERS is the national spontaneous vaccine safety surveillance system coadministered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adults aged ≥19 years who received the MMR vaccine from 1 January 2003 to 31 July 2013. We clinically reviewed reports and available medical records for serious AEs, pregnancy reports, and reports for selected prespecified outcomes.

RESULTS

During this period, VAERS received 3175 US reports after MMR vaccine in adults. Of these, 168 (5%) were classified as serious, including 7 reports of death. Females accounted for 77% of reports. The most common signs and symptoms for all reports were pyrexia (19%), rash (17%), pain (13%), and arthralgia (13%). We did not detect any new safety findings in empirical Bayesian data mining. We identified 131 reports of MMR vaccine administered to a pregnant woman; the majority of these vaccinations were in the first trimester and in 83 (62%), no AE was reported.

CONCLUSIONS

In our review of VAERS data, we did not detect any new or unexpected safety concerns for MMR vaccination in adults. We identified reports of pregnant women exposed to MMR, which is a group in whom the vaccine is contraindicated, suggesting the need for continued provider education on vaccine recommendations and screening.

摘要

背景

关于成人麻疹、腮腺炎和风疹(MMR)疫苗安全性的数据有限。我们回顾了疫苗不良事件报告系统(VAERS)中的不良事件(AE)报告,以评估这一此前研究较少群体的安全性。

方法

VAERS是由疾病控制与预防中心和美国食品药品监督管理局共同管理的全国性自发疫苗安全性监测系统。我们在VAERS数据库中搜索了2003年1月1日至2013年7月31日期间美国19岁及以上成年人接种MMR疫苗的报告。我们对严重不良事件报告、妊娠报告以及选定的预先指定结局报告进行了临床审查,并查阅了可用的医疗记录。

结果

在此期间,VAERS收到了3175份美国成年人接种MMR疫苗后的报告。其中,168份(5%)被归类为严重报告,包括7份死亡报告。女性占报告的77%。所有报告中最常见的体征和症状为发热(19%)、皮疹(17%)、疼痛(13%)和关节痛(13%)。在经验贝叶斯数据挖掘中,我们未发现任何新的安全性发现。我们识别出131份给孕妇接种MMR疫苗的报告;这些接种大多数发生在孕早期,83份(62%)报告中未出现不良事件。

结论

在我们对VAERS数据的回顾中,未发现成人接种MMR疫苗有任何新的或意外的安全问题。我们识别出孕妇接触MMR疫苗的报告,而孕妇是该疫苗的禁忌人群,这表明需要持续对医疗服务提供者进行疫苗推荐和筛查方面的教育。

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