title: Adverse events after Fluzone ® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013.
abstract: BACKGROUND
  In May 2011, the first trivalent inactivated influenza vaccine exclusively for intradermal administration (TIV-ID) was licensed in the US for adults aged 18-64 years.
  
  
  OBJECTIVE
  To characterize adverse events (AEs) after TIV-ID reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
  
  
  METHODS
  We searched VAERS for US reports after TIV-ID among persons vaccinated from July 1, 2011-February 28, 2013. Medical records were requested for reports coded as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis. Clinicians reviewed available information and assigned a primary clinical category to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following TIV-ID. Causality was not assessed.
  
  
  RESULTS
  VAERS received 466 reports after TIV-ID; 9 (1.9%) were serious, including one reported fatality in an 88-year-old vaccinee. Median age was 43 years (range 4-88 years). The most common AE categories were: 218 (46.8%) injection site reactions; 89 (19.1%) other non-infectious (comprised mainly of constitutional signs and symptoms); and 74 (15.9%) allergy. Eight reports (1.7%) of anaphylaxis were verified by the Brighton criteria or a documented physician diagnosis. Disproportional reporting was identified for three AEs: 'injection site nodule', 'injection site pruritus', and 'drug administered to patient of inappropriate age'. The findings for the first two AEs were expected. Twenty-four reports of vaccinees <18 years or ≥ 65 years were reported, and 14 of 24 were coded with the AE 'drug administered to patient of inappropriate age'.
  
  
  CONCLUSIONS
  Review of VAERS reports did not identify any new or unexpected safety concerns after TIV-ID. Injection site reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Use of TIV-ID in younger and older individuals outside the approved age range highlights the need for education of healthcare providers regarding approved TIV-ID use.
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States. Electronic address: psm9@cdc.gov.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.forename: Theresa
authors.initials: T
authors.lastname: Harrington
authors.forename: Tom
authors.initials: T
authors.lastname: Shimabukuro
authors.forename: Maria
authors.initials: M
authors.lastname: Cano
authors.forename: Oidda I
authors.initials: OI
authors.lastname: Museru
authors.forename: David
authors.initials: D
authors.lastname: Menschik
authors.forename: Karen
authors.initials: K
authors.lastname: Broder
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D014481:United States; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Adverse event; Intradermal; Surveillance; Trivalent inactivated influenza vaccine; Vaccine safety