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American Journal of Obstetrics and Gynecology
Article in Press, Accepted Manuscript - Note to users
doi:10.1016/j.ajog.2011.06.047 | How to Cite or Link Using DOI
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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 MD, MPH1, Corresponding Author Contact Information, E-mail The Corresponding Author, Karen Broder MD1, Yenlik Zheteyeva MD, MPH2, Natalya Revzina MD3, Naomi Tepper MD, MPH3, Dmitry Kissin MD, MPH3, Faith Barash MD, MPH4, Jorge Arana MD, MPH1, Mary D. Brantley MPH5, Helen Ding MD, MSPH6, James A. Singleton MS6, Kimp Walton MS1, Penina Haber MPH1, Paige Lewis MSPH1, Xin Yue MS1, Frank Destefano MD, MPH1 and Claudia Vellozzi MD, MPH1
1 Immunization Safety Office, Division of Healthcare Quality Promotion,National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)
2 Epidemic Intelligence Service, Office of Workforce and Career Development, Office of the Director
3 Women's Health and Fertility Branch, Division of Reproductive Health,National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), CDC
4 Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration
5 Applied Sciences Branch, Division of Reproductive Health, NCCDPHP, CDC
6 Assessment Branch, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC
Received 15 February 2011;
revised 27 April 2011;
accepted 9 June 2011.
Available online 21 June 2011.
Abstract
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 10/01/2009-02/28/2010.
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.
Article in Press, Accepted Manuscript - Note to users
doi:10.1016/j.ajog.2011.06.047 | How to Cite or Link Using DOI
Permissions & Reprints
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 MD, MPH1, Corresponding Author Contact Information, E-mail The Corresponding Author, Karen Broder MD1, Yenlik Zheteyeva MD, MPH2, Natalya Revzina MD3, Naomi Tepper MD, MPH3, Dmitry Kissin MD, MPH3, Faith Barash MD, MPH4, Jorge Arana MD, MPH1, Mary D. Brantley MPH5, Helen Ding MD, MSPH6, James A. Singleton MS6, Kimp Walton MS1, Penina Haber MPH1, Paige Lewis MSPH1, Xin Yue MS1, Frank Destefano MD, MPH1 and Claudia Vellozzi MD, MPH1
1 Immunization Safety Office, Division of Healthcare Quality Promotion,National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)
2 Epidemic Intelligence Service, Office of Workforce and Career Development, Office of the Director
3 Women's Health and Fertility Branch, Division of Reproductive Health,National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), CDC
4 Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration
5 Applied Sciences Branch, Division of Reproductive Health, NCCDPHP, CDC
6 Assessment Branch, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC
Received 15 February 2011;
revised 27 April 2011;
accepted 9 June 2011.
Available online 21 June 2011.
Abstract
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 10/01/2009-02/28/2010.
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.
