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

被引：92

作者：

Moro, Pedro L. ^{[1
]}

Broder, Karen ^{[1
]}

Zheteyeva, Yenlik ^{[2
]}

Revzina, Natalya ^{[3
]}

Tepper, Naomi ^{[3
]}

Kissin, Dmitry ^{[3
]}

Barash, Faith ^{[6
]}

Arana, Jorge ^{[1
]}

Brantley, Mary D. ^{[4
]}

Ding, Helen ^{[5
]}

Singleton, James A. ^{[5
]}

Walton, Kimp ^{[1
]}

Haber, Penina ^{[1
]}

Lewis, Paige ^{[1
]}

Yue, Xin ^{[1
]}

DeStefano, Frank ^{[1
]}

Vellozzi, Claudia ^{[1
]}

机构：

[1] Ctr Dis Control & Prevent, Immunizat Safety Off, Div Healthcare Qual Promot, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA

[2] Ctr Dis Control & Prevent, Epidem Intelligence Serv, Off Workforce & Career Dev, Off Director, Atlanta, GA 30333 USA

[3] Ctr Dis Control & Prevent, Womens Hlth & Fertil Branch, Div Reprod Hlth, Natl Ctr Chron Dis Prevent & Hlth Promot, Atlanta, GA 30333 USA

[4] Ctr Dis Control & Prevent, Appl Sci Branch, Div Reprod Hlth, Natl Ctr Chron Dis Prevent & Hlth Promot, Atlanta, GA 30333 USA

[5] Ctr Dis Control & Prevent, Assessment Branch, Immunizat Serv Div, Natl Ctr Immunizat & Resp Dis, Atlanta, GA 30333 USA

[6] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA

来源：

AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY | 2011年 / 205卷 / 05期

关键词：

influenza A (H1N1); pregnancy; surveillance; vaccine safety; IMMUNIZATION SAFETY DATA; UNITED-STATES; ROTAVIRUS VACCINE; CASE DEFINITIONS; BELLS-PALSY; INTUSSUSCEPTION; GUIDELINES; PREECLAMPSIA; COLLECTION; CHILDREN;

D O I：

10.1016/j.ajog.2011.06.047

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

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.

引用

页码：473.e1 / 473.e9

页数：9

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