title: Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women.
abstract: OBJECTIVE
  To characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
  
  
  METHODS
  We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. Clinicians reviewed all reports and available medical records.
  
  
  RESULTS
  VAERS received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; no maternal or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and preterm delivery in 7 (5.0%) reports. The most common nonpregnancy specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization.
  
  
  CONCLUSIONS
  This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal Hep A or Hep AB immunizations during pregnancy.
authors.affiliation: Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Oidda I
authors.initials: OI
authors.lastname: Museru
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD.
authors.forename: Manette
authors.initials: M
authors.lastname: Niu
authors.affiliation: Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Karen
authors.initials: K
authors.lastname: Broder
mesh_terms: D000022:Abortion, Spontaneous / Q000453:epidemiology; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006506:Hepatitis A / Q000276:immunology*; D006509:Hepatitis B / Q000276:immunology*; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D047928:Premature Birth / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014552:Urinary Tract Infections / Q000453:epidemiology; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects*
chemical_list: D014761:Viral Hepatitis Vaccines
keywords: hepatitis A hepatitis B combined vaccine; hepatitis A vaccine; pregnancy; surveillance; vaccine safety