Moro Pedro L, Woo Emily Jane, Paul Wendy, Lewis Paige, Petersen Brett W, Cano Maria
Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of America.
Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.
PLoS Negl Trop Dis. 2016 Jul 13;10(7):e0004846. doi: 10.1371/journal.pntd.0004846. eCollection 2016 Jul.
In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States.
To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV.
VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination.
This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.
1980年，人二倍体细胞疫苗（HDCV，Imovax狂犬病疫苗，赛诺菲巴斯德公司生产）在美国获得使用许可。
评估向美国疫苗不良事件报告系统（VAERS，一个自发报告监测系统）报告的接种HDCV后的不良事件（AE）。
我们在VAERS中搜索了1990年1月1日至2015年7月31日期间接种HDCV的美国报告。对于分类为严重（死亡、住院、延长住院时间、残疾、危及生命的疾病）以及提示过敏反应和吉兰-巴雷综合征（GBS）的报告，要求提供医疗记录。医生审查了可用信息，并使用MedDRA系统器官分类为每份报告指定一个主要临床类别。采用经验贝叶斯（EB）数据挖掘来识别接种HDCV后不成比例的AE报告。
VAERS收到了1611份接种HDCV后的报告；93份（5.8%）为严重报告。在所有报告中，三种最常见的AE包括发热（18.2%）、头痛（17.9%）和恶心（16.5%）。在严重报告中，有4例死亡似乎与疫苗接种无关。
对VAERS的这25年回顾未发现接种HDCV后有新的或意外的AE。绝大多数AE不严重。注射部位反应、过敏反应和非特异性全身症状报告最为频繁，与上市前研究结果相似。
