title: Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013.
abstract: BACKGROUND
  Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults.
  
  
  METHODS
  We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season.
  
  
  RESULTS
  During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS.
  
  
  CONCLUSIONS
  Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications.
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA. Electronic address: pyh0@cdc.gov.
authors.forename: Penina
authors.initials: P
authors.lastname: Haber
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
authors.forename: Michael M
authors.initials: MM
authors.lastname: McNeil
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA.
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
authors.affiliation: Safety and Evaluation Division, Military Vaccine Agency (MILVAX), Falls Church, VA 22042, USA.
authors.forename: Hayley
authors.initials: H
authors.lastname: Hughes
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
authors.forename: Tom T
authors.initials: TT
authors.lastname: Shimabukuro
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001499:Bayes Theorem; D002487:Centers for Disease Control and Prevention, U.S.; D057225:Data Mining; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D014613:Vaccines, Attenuated / Q000009:adverse effects; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated
keywords: Live attenuated influenza vaccine; Post-licensure surveillance; Vaccine safety