| アブストラクト | BACKGROUND: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. OBJECTIVE: To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: 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-Barre 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. RESULTS: 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. CONCLUSIONS: 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. |
|---|
| ジャーナル名 | PLoS neglected tropical diseases |
|---|
| 投稿日 | 2016/7/15 |
|---|
| 投稿者 | Moro, Pedro L; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W; Cano, Maria |
|---|
| 組織名 | 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.;Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology,;NCZEID, CDC, Atlanta, Georgia, United States of America. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27410239/ |
|---|
