title: Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax(®)) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015.
abstract: BACKGROUND
  In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥ 18 years.
  
  
  OBJECTIVE
  To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
  
  
  METHODS
  We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 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 using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3.
  
  
  RESULTS
  VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons <18 years. Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.'
  
  
  CONCLUSIONS
  Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use.
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States. Electronic address: pmoro@cdc.gov.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, United States.
authors.forename: Scott
authors.initials: S
authors.lastname: Winiecki
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States.
authors.forename: Tom T
authors.initials: TT
authors.lastname: Shimabukuro
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States.
authors.forename: Maria
authors.initials: M
authors.lastname: Cano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018929:Cell Culture Techniques / Q000379:methods; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D013678:Technology, Pharmaceutical / Q000379:methods; D014481:United States / Q000453:epidemiology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Adverse event; Cell culture; Surveillance; Trivalent inactivated influenza vaccine; Vaccine safety