title: Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System.
abstract: OBJECTIVE
  The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems.
  
  
  METHODS
  We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010.
  
  
  RESULTS
  VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks); 18 stillbirths (≥20 weeks); 7 preterm deliveries (<37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip.
  
  
  CONCLUSIONS
  Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. pmoro@cdc.gov
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.forename: Karen
authors.initials: K
authors.lastname: Broder
authors.forename: Yenlik
authors.initials: Y
authors.lastname: Zheteyeva
authors.forename: Natalya
authors.initials: N
authors.lastname: Revzina
authors.forename: Naomi
authors.initials: N
authors.lastname: Tepper
authors.forename: Dmitry
authors.initials: D
authors.lastname: Kissin
authors.forename: Faith
authors.initials: F
authors.lastname: Barash
authors.forename: Jorge
authors.initials: J
authors.lastname: Arana
authors.forename: Mary D
authors.initials: MD
authors.lastname: Brantley
authors.forename: Helen
authors.initials: H
authors.lastname: Ding
authors.forename: James A
authors.initials: JA
authors.lastname: Singleton
authors.forename: Kimp
authors.initials: K
authors.lastname: Walton
authors.forename: Penina
authors.initials: P
authors.lastname: Haber
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.forename: Xin
authors.initials: X
authors.lastname: Yue
authors.forename: Frank
authors.initials: F
authors.lastname: Destefano
authors.forename: Claudia
authors.initials: C
authors.lastname: Vellozzi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D061214:Patient Safety; D011247:Pregnancy; D014613:Vaccines, Attenuated / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated