Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Nov;205(5):473.e1-9.
doi: 10.1016/j.ajog.2011.06.047. Epub 2011 Jun 21.

Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System

Pedro L Moro  1 , Karen Broder, Yenlik Zheteyeva, Natalya Revzina, Naomi Tepper, Dmitry Kissin, Faith Barash, Jorge Arana, Mary D Brantley, Helen Ding, James A Singleton, Kimp Walton, Penina Haber, Paige Lewis, Xin Yue, Frank Destefano, Claudia Vellozzi
Affiliations

Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System

Pedro L Moro et al. Am J Obstet Gynecol. 2011 Nov.

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.

Study design: 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.

Conclusion: Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Monthly Reports of spontaneous abortions, stillbirth and allergic reactions among pregnant women who received 2009 H1N1 vaccine and who reported to VAERS
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Fiore AE, Shay DK, Broder K, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009; 58:1–52. - PubMed
    1. Skowronski DM, De Serres G. Is routine influenza immunization warranted in early pregnancy? Vaccine 2009; 27:4754–70. - PubMed
    1. CDC. Swine Influenza A (H1N1) Infection in Two Children --- Southern California, March--April 2009. MMWR. 2009; 58:400–2. - PubMed
    1. Jamieson DJ, Honein MA, Rasmussen SA, et al. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet 2009; 374:451–8. - PubMed
    1. CDC. Use of Influenza A (H1N1) 2009 Monavalent Vaccine Recommendations of the Advisory Committee on Immunization Practices. MMWR; 2009; 58:1–8. - PubMed

MeSH terms