Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System

OBJECTIVE: We characterized reports to the Vaccine Adverse Event (AE) Reporting System (VAERS) of pregnant women who received meningococcal polysaccharide-protein conjugate vaccine Menactra (MenACWY-D; Sanofi Pasteur Inc., Swiftwater, PA). STUDY DESIGN: We searched VAERS for reports of pregnant women who received MenACWY-D from Jan. 1, 2005 through Dec. 31, 2011. We conducted clinical review of reports and available medical records. RESULTS: Of 103 identified reports, 38 (36.7%) did not describe any AE. No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 17 (16.5%) reports. Urinary tract infections and fever with vomiting were the most frequent nonpregnancy-specific AEs found in 4 (3.9%) and 3 (2.9%) reports, respectively. We identified 1 report with a major congenital anomaly (aqueductal stenosis and severe ventriculomegaly). CONCLUSION: Our comprehensive review of reports to VAERS in pregnant women after MenACWY-D did not identify any concerning patterns in maternal, infant, or fetal outcomes.