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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 (VAERS).
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June 21 2011
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Source: Am J Obstet Gynecol. 205(5):473.e1-473.e9
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Details:
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Alternative Title:Am J Obstet Gynecol
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Personal Author:
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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.
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Source:
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Pubmed ID:21861964
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Pubmed Central ID:PMC6602056
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Document Type:
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Funding:
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Volume:205
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Issue:5
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