title: Vaccine adverse events in a safety net healthcare system and a managed care organization.
abstract: The Institute of Medicine, in a 2013 report, recommended that the Vaccine Safety Datalink (VSD) expand collaborations to include more diversity in the study population. Kaiser Permanente Colorado (KPCO), an established VSD site, partnered with Denver Health (DH), an integrated safety net healthcare system, to demonstrate the feasibility of integrating DH data within the VSD. Prior to incorporating the data, we examined the identification of specific vaccine associated adverse events (VAEs) in these two distinct healthcare systems.
  
  
  
  We conducted retrospective cohort analyses within KPCO and DH to compare select VAEs between the two populations. We examined the following associations between January 1, 2004 and December 31, 2013: Measles, Mumps, and Rubella (MMR) vaccine and febrile seizures in children 2years and younger, intussusception after rotavirus vaccine in infants 4-34weeks, syncope after adolescent vaccines (Tetanus, Diphtheria, acellular Pertussis; Meningococcal and Human Papillomavirus) in adolescents 13-17years and medically attended local reactions after pneumococcal polysaccharide (PPSV23) vaccine in adults 65years and older. Both sites used similar data procurement methods and chart review processes.
  
  
  
  For seizures after MMR vaccine (KPCO - 3.15vs. DH - 2.97/10,000 doses) and syncope after all adolescent vaccines (KPCO - 3.0vs. DH - 2.37/10,000 doses), the chart confirmed rates were comparable at the two sites. However, for medically attended local reactions after PPSV23, there were differences in chart confirmed rates between the sites (KPCO - 31.65vs. DH - 14.90/10,000 doses). For intussusception after rotavirus vaccine, the number of cases was too low to make a valid comparison (KPCO - 0vs. DH - 0.13/10,000 doses).
  
  
  
  We demonstrated that data on important targeted VAEs can be captured at DH and rates appear similar to those at KPCO. Work is ongoing on the optimal approach to assimilate DH data as a potential safety net healthcare system in the VSD.
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, United States. Electronic address: Komal.j.narwaney@kp.org.
authors.forename: Komal J
authors.initials: KJ
authors.lastname: Narwaney
authors.affiliation: Ambulatory Care Services, Denver Health, United States.
authors.forename: Kristin
authors.initials: K
authors.lastname: Breslin
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, United States.
authors.forename: Colleen A
authors.initials: CA
authors.lastname: Ross
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, United States.
authors.forename: Jo Ann
authors.initials: JA
authors.lastname: Shoup
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, United States.
authors.forename: Kris F
authors.initials: KF
authors.lastname: Wain
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Weintraub
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, United States.
authors.forename: Michael M
authors.initials: MM
authors.lastname: McNeil
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, United States; Ambulatory Care Services, Denver Health, United States; Pediatrics and Epidemiology, University of Colorado, United States.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Hambidge
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D003120:Colorado; D003695:Delivery of Health Care; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016247:Information Storage and Retrieval; D008297:Male; D008329:Managed Care Programs; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D011159:Population Surveillance; D012189:Retrospective Studies; D014481:United States; D014611:Vaccination; D014612:Vaccines / Q000009:adverse effects*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D022401:Meningococcal Vaccines; D014612:Vaccines; D017778:Vaccines, Combined
keywords: Population surveillance; Safety net health system; Vaccine safety