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Assessing the safety of 9-valent human papillomavirus vaccine administration among pregnant women: adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014–2017
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January 16 2019
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Source: Vaccine. 37(9):1229-1234
[PDF-773.06 KB]
Details:
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Alternative Title:Vaccine
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Personal Author:
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Description:Introduction
9-valent human papillomavirus vaccine (9vHPV) was approved by the Food and Drug Administration (FDA) in December 2014. 9vHPV is not recommended during pregnancy but it is possible that some women of childbearing age might be inadvertently exposed prior to knowing they are pregnant. This study aims to assess the safety of 9vHPV administration during pregnancy.
Methods
We searched the Vaccine Adverse Event Reporting System (VAERS) database, a national post-licensure vaccine safety surveillance system, for reports of pregnant women vaccinated with 9vHPV in the United States between December 10, 2014 and December 31, 2017. Disproportionate reporting of adverse events (AEs) was assessed using proportional reporting ratios (PRRs).
Results
A total of 82 pregnancy reports were identified. Sixty reports (73.2%) did not describe an AE and were submitted only to report the vaccine exposure during pregnancy. The most frequently reported pregnancy-specific AE was spontaneous abortion (n = 3; 3.7%), followed by vaginal bleeding (n = 2; 2.4%). Among non-pregnancy-specific AEs, injection site reaction (n = 3; 3.7%) was most common. No disproportional reporting for any AE was found.
Discussion
No unexpected AEs were observed among these pregnancy reports.
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Pubmed ID:30660400
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Pubmed Central ID:PMC6505695
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