Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States,1990‒2015

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. © 2016 public library of science. all rights reserved.