Details:

Alternative Title:
PLoS Negl Trop Dis
Publisher's site:
http://dx.doi.org/10.1371/journal.pntd.0004846
Personal Author:
Moro, Pedro L. ; Woo, Emily Jane ; Paul, Wendy ; Lewis, Paige ; Petersen, Brett W. ; ... More +
Moro, Pedro L. ; Woo, Emily Jane ; Paul, Wendy ; Lewis, Paige ; Petersen, Brett W. ; Cano, Maria ; Less -
Description:
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-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. 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.
Subject:
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Adverse Drug Reaction Reporting Systems
Cell Culture Techniques
Drug-Related Side Effects And Adverse Reactions
Humans
Product Surveillance, Postmarketing
Rabies Vaccines

Source:
PLoS Negl Trop Dis. 10(7). ;
Pubmed ID:
27410239
Pubmed Central ID:
PMC4943633
Document Type:
Journal Article ;
Name as Subject:
Vaccine Adverse Event Reporting System ;
Place as Subject:
United States ;
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:018e7807813560f1694c9e7e91e830a938388fc225e7d69551457c7d0c5df973
File Type:

Supporting Files

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