Adverse Events following Administration to Pregnant Women of Influenza A (H1N1) 2009 Monovalent Vaccine reported to the Vaccine Adverse Event Reporting System (VAERS).

Details

• Alternative Title:
  Am J Obstet Gynecol
• Personal Author:
  MORO, Pedro L. ; BRODER, Karen ; ZHETEYEVA, Yenlik ; REVZINA, Natalya ; TEPPER, Naomi ; KISSIN, Dmitry ; BARASH, Faith ; ARANA, Jorge ; BRANTLEY, Mary D. ; DING, Helen ; SINGLETON, James A. ; WALTON, Kimp ; HABER, Penina ; LEWIS, Paige ; YUE, Xin ; DESTEFANO, Frank ; VELLOZZI, Claudia
• Description:
  Objective:
  
  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 10/0½009–02/28/2010.
  
  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 (20.1%) women 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.
  
  
• Subjects:
  Adverse Drug Reaction Reporting Systems Article Female Humans Influenza, Human Influenza A Virus, H1N1 Subtype Influenza Vaccines Patient Safety Pregnancy Vaccines, Attenuated
• Source:
  Am J Obstet Gynecol. 205(5):473.e1-473.e9
• Pubmed ID:
  21861964
• Pubmed Central ID:
  PMC6602056
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Volume:
  205
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:8224f55b201016e22767e1d3e104da6fb302593872ef83d393e3b392aa4865be
• Download URL:
  https://stacks.cdc.gov/view/cdc/79583/cdc_79583_DS1.pdf
• File Type:
  [PDF - 188.28 KB ]