title: Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013.
abstract: OBJECTIVE
  To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
  
  
  METHODS
  We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to December 1, 2013. We reviewed a random sample of reports and accompanying medical records for reports classified as serious. All reports of death were reviewed. Physicians assigned a primary clinical category to each reviewed report. We used empirical Bayesian data mining to identify AEs that were disproportionally reported after Hib vaccines.
  
  
  RESULTS
  VAERS received 29,747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.
  
  
  CONCLUSIONS
  Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA. Electronic address: pmoro@cdc.gov.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Christopher
authors.initials: C
authors.lastname: Jankosky
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: David
authors.initials: D
authors.lastname: Menschik
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Duffy
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Brock
authors.initials: B
authors.lastname: Stewart
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Tom T
authors.initials: TT
authors.lastname: Shimabukuro
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D016667:Bacterial Capsules; D001499:Bayes Theorem; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006192:Haemophilus Infections / Q000401:mortality / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000009:adverse effects*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology
chemical_list: D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine