Claudia S Landazabal1, Pedro L Moro2, Paige Lewis3, Saad B Omer4. 1. Emory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: claudialandazabal@alumni.emory.edu. 2. Centers for Disease Control and Prevention, National Center for Zoonotic and Emerging Infectious Diseases, Division of Healthcare Quality Promotion, Immunization Safety Office, 1600 Clifton Road, Atlanta, GA 30333, United States. Electronic address: psm9@cdc.gov. 3. Centers for Disease Control and Prevention, National Center for Zoonotic and Emerging Infectious Diseases, Division of Healthcare Quality Promotion, Immunization Safety Office, 1600 Clifton Road, Atlanta, GA 30333, United States. Electronic address: fqv9@cdc.gov. 4. Emory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory University Rollins School of Public Health, Hubert Department of Global Health, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory Vaccine Center, 954 Gatewood Road, Atlanta, GA 30329, United States. Electronic address: somer@emory.edu.
Abstract
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 some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women exposed to 9vHPV. METHODS: We searched the 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 disproportionate reporting of any AE was found. DISCUSSION: No unexpected AEs were observed among these pregnancy reports.
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 some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women exposed to 9vHPV. METHODS: We searched the 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 disproportionate reporting of any AE was found. DISCUSSION: No unexpected AEs were observed among these pregnancy reports.
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