Reports to the Vaccine Adverse Event Reporting System indicate 2009 H1N1 vaccination is safe
THURSDAY, Nov. 3 (HealthDay News) -- Administration of the influenza A (H1N1) vaccine to pregnant women seems to be safe and is not associated with an increase in adverse maternal or fetal outcomes, according to a study published in the November issue of the American Journal of Obstetrics & Gynecology.
Pedro L. Moro, M.D., M.P.H., from the National Center for Emerging and Zoonotic Infectious Diseases in Atlanta, and colleagues used reports to the Vaccine Adverse Event Reporting System (VAERS) to assess potential vaccine safety problems in pregnant women who received the 2009 H1N1 monovalent vaccine. Reports of adverse events were received from pregnant women who were vaccinated from October 2009 through February 2010.
The investigators received 294 reports of adverse events: 288 following receipt of inactivated vaccines and six following live attenuated vaccines. There were two maternal deaths, and 20.1 percent of women were hospitalized. A total of 131 pregnancy-specific outcomes were verified: 95 spontaneous abortions (<20 weeks) and 18 stillbirths (≥20 weeks). There were seven preterm deliveries before 37 weeks, three threatened abortions, two cases of preterm labor, two cases of preeclampsia, and one case each of fetal tachycardia, fetal hydronephrosis, intrauterine growth retardation, and cleft lip.
"Our review of VAERS reports following 2009 H1N1 vaccination has provided a comprehensive and rapid assessment of the safety of inactivated 2009 H1N1 vaccine among
pregnant women," the authors write.
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