title: Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women.
abstract: OBJECTIVE
  To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events.
  
  
  METHODS
  We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated.
  
  
  RESULTS
  The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis.
  
  
  CONCLUSIONS
  Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified.
  
  
  METHODS
  : III.
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, the Birth Defects Branch, Division of Birth Defects & Developmental Disabilities, National Center on Birth Defects & Developmental Disabilities, the Epidemic Intelligence Service, Epidemiology Workforce Branch, Office of Public Health Scientific Services, and the Women's Health and Fertility Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, and the Department of Pediatrics, Emory School of Medicine, Atlanta, Georgia; and the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Moro
authors.forename: Oidda I
authors.initials: OI
authors.lastname: Museru
authors.forename: Karen
authors.initials: K
authors.lastname: Broder
authors.forename: Janet
authors.initials: J
authors.lastname: Cragan
authors.forename: Yenlik
authors.initials: Y
authors.lastname: Zheteyeva
authors.forename: Naomi
authors.initials: N
authors.lastname: Tepper
authors.forename: Natalia
authors.initials: N
authors.lastname: Revzina
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.forename: Jorge
authors.initials: J
authors.lastname: Arana
authors.forename: Faith
authors.initials: F
authors.lastname: Barash
authors.forename: Dmitry
authors.initials: D
authors.lastname: Kissin
authors.forename: Claudia
authors.initials: C
authors.lastname: Vellozzi
mesh_terms: D000022:Abortion, Spontaneous / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D000013:Congenital Abnormalities / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D050498:Live Birth; D008297:Male; D011247:Pregnancy; D047928:Premature Birth / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology; D062690:Vaccines, Live, Unattenuated / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D062690:Vaccines, Live, Unattenuated