AccScience Publishing / MI / Online First / DOI: 10.36922/MI025310073
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ORIGINAL RESEARCH ARTICLE

Safety of the 9-valent human papillomavirus vaccine in pregnancy based on the vaccine adverse event reporting system

Sarah Boudova1* ,  Christopher V. Chambers2 ,  Rupsa C. Boelig3
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1 Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Illinois Chicago, Chicago, Illinois, United States of America
2 Department of Family and Community Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America
3 Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America
MI, 025310073 https://doi.org/10.36922/MI025310073
Received: 31 July 2025 | Revised: 3 September 2025 | Accepted: 24 October 2025 | Published online: 4 December 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Current guidelines recommend against administering the 9-valent human papillomavirus (HPV) vaccine during pregnancy due to limited safety data. We examined adverse events reported in patients receiving the 9-valent HPV vaccine during pregnancy. The Vaccine Adverse Events Reporting System (VAERS) database was queried for “exposure during pregnancy” to the 9-valent HPV vaccine. Cases were excluded if there was no information on pregnancy in the report or the patient was not pregnant at the time of vaccination. Individual reports were reviewed and data were extracted on gestational age and adverse pregnancy events. From the 285 reports identified, 273 were included. 40.3% (110/273) of the reports stated that there were no adverse events following vaccination. There were eight reports of mild maternal reactions (most commonly injection site pain) and one report of a serious reaction (angioedema). The majority of reports (257/273, 94.1%) did not include the pregnancy outcome. There was one case of vaginal bleeding, four miscarriages, one elective abortion, no stillbirths, and two congenital anomalies. There were seven reports of live births. 61.5% (168/273) of the reports included gestational age at the time of vaccination. Few cases of pregnancy-related adverse events were identified following 9-valent HPV vaccine administration. The VAERS database is an electively reported database; thus, the incidence of events could not be determined, and many reports were incomplete. Despite these limitations, the low numbers of adverse events are reassuring. Clinical trials are warranted to conclusively examine the safety and efficacy of HPV vaccination during pregnancy.

Keywords
Human papillomavirus
Vaccination
Vaccine Adverse Events Reporting System
Pregnancy
Gestational age
Congenital vaccine exposure
Funding
None.
Conflict of interest
The authors declare that they have no competing interests.
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