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Safety of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Pregnancy: Review of Non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006 – 2013
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December 08 2014
Source: Vaccine. 33(4):519-522 -
Alternative Title:Vaccine
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Personal Author:
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Description:Background:
In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co. Inc.) vaccine was licensed in the US for use in females aged 9 to 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 6/1/2006–12/31/2013. 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-five (71.4%) 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.
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Pubmed ID:25500173
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Pubmed Central ID:PMC6524774
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