title: Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013.
abstract: BACKGROUND
  In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur.
  
  
  OBJECTIVE
  To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among non-manufacturer reports.
  
  
  METHODS
  We searched the VAERS database for non-manufacturer reports of adverse events (AEs) in pregnant women who received HPV4 vaccine from 6/1/2006 to 12/31/2013. We conducted clinical review of reports and available medical records.
  
  
  RESULTS
  We found 147 reports after HPV4 vaccine administered to pregnant women. The most frequent pregnancy-specific AE was spontaneous abortion in 15 (10.2%) reports, followed by elective terminations in 6 (4.1%). Maternal fever was the most frequent non-pregnancy-specific AE in 3 reports. Two reports of major birth defects were received. No maternal deaths were noted. One hundred-three (70.1%) reports did not describe an AE.
  
  
  CONCLUSIONS
  This review of VAERS non-manufacturer reports following vaccination with HPV4 in pregnancy did not find any unexpected patterns in maternal or fetal outcomes.
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), United States. Electronic address: psm9@cdc.gov.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.affiliation: Community Interventions for Infection Control Unit, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention (CDC), United States.
authors.forename: Yenlik
authors.initials: Y
authors.lastname: Zheteyeva
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), United States.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: HIV Incidence and Case Surveillance Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, United States.
authors.forename: Jing
authors.initials: J
authors.lastname: Shi
authors.affiliation: Assessment Branch, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC, United States.
authors.forename: Xin
authors.initials: X
authors.lastname: Yue
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), United States.
authors.forename: Oidda I
authors.initials: OI
authors.lastname: Museru
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), United States.
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*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D007231:Infant, Newborn; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011256:Pregnancy Outcome; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines
keywords: Adverse events; Epidemiology; Pregnancy; Quadrivalent human papillomavirus vaccine; Surveillance; Vaccine safety