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. 2015 Jan 15;33(4):519-22.
doi: 10.1016/j.vaccine.2014.11.047. Epub 2014 Dec 8.

Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013

Pedro L Moro  1 , Yenlik Zheteyeva  2 , Paige Lewis  3 , Jing Shi  4 , Xin Yue  5 , Oidda I Museru  3 , Karen Broder  3
Affiliations

Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013

Pedro L Moro et al. Vaccine. .

Abstract

Background: In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur.

Objectives: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among non-manufacturer reports.

Methods: We searched the VAERS database for non-manufacturer reports of adverse events (AEs) in pregnant women who received HPV4 vaccine from 6/1/2006 to 12/31/2013. We conducted clinical review of reports and available medical records.

Results: We found 147 reports after HPV4 vaccine administered to pregnant women. The most frequent pregnancy-specific AE was spontaneous abortion in 15 (10.2%) reports, followed by elective terminations in 6 (4.1%). Maternal fever was the most frequent non-pregnancy-specific AE in 3 reports. Two reports of major birth defects were received. No maternal deaths were noted. One hundred-three (70.1%) reports did not describe an AE.

Conclusions: This review of VAERS non-manufacturer reports following vaccination with HPV4 in pregnancy did not find any unexpected patterns in maternal or fetal outcomes.

Keywords: Adverse events; Epidemiology; Pregnancy; Quadrivalent human papillomavirus vaccine; Surveillance; Vaccine safety.

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References

    1. Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, 18] vaccine, recombinant): product information and supporting documents. Food and Drug Administration. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm0... Accessed on October 1, 2013
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