| アブストラクト | 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. |
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| 組織名 | Immunization Safety Office, Division of Healthcare Quality Promotion, National;Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for;Disease Control and Prevention (CDC), United States. Electronic address:;psm9@cdc.gov.;Community Interventions for Infection Control Unit, Division of Global Migration;and Quarantine, Centers for Disease Control and Prevention (CDC), United States.;Disease Control and Prevention (CDC), United States.;HIV Incidence and Case Surveillance Branch, Division of HIV/AIDS Prevention,;National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC,;United States.;Assessment Branch, Immunization Services Division, National Center for;Immunization and Respiratory Diseases, CDC, United States. |
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