title: Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.
abstract: 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.
authors.affiliation: 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.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.
authors.forename: Wendy
authors.initials: W
authors.lastname: Paul
authors.affiliation: 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.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, NCZEID, CDC, Atlanta, Georgia, United States of America.
authors.forename: Brett W
authors.initials: BW
authors.lastname: Petersen
authors.affiliation: 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.
authors.forename: Maria
authors.initials: M
authors.lastname: Cano
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D018929:Cell Culture Techniques / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011819:Rabies Vaccines / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology
chemical_list: D011819:Rabies Vaccines