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Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013.
Vaccine. 2015 Jan 15; 33(4):519-22.V

Abstract

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.

Authors+Show Affiliations

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.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.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.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.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.

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

25500173

Citation

Moro, Pedro L., et al. "Safety of Quadrivalent Human Papillomavirus Vaccine (Gardasil) in Pregnancy: Adverse Events Among Non-manufacturer Reports in the Vaccine Adverse Event Reporting System, 2006-2013." Vaccine, vol. 33, no. 4, 2015, pp. 519-22.
Moro PL, Zheteyeva Y, Lewis P, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine. 2015;33(4):519-22.
Moro, P. L., Zheteyeva, Y., Lewis, P., Shi, J., Yue, X., Museru, O. I., & Broder, K. (2015). Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine, 33(4), 519-22. https://doi.org/10.1016/j.vaccine.2014.11.047
Moro PL, et al. Safety of Quadrivalent Human Papillomavirus Vaccine (Gardasil) in Pregnancy: Adverse Events Among Non-manufacturer Reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine. 2015 Jan 15;33(4):519-22. PubMed PMID: 25500173.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. AU - Moro,Pedro L, AU - Zheteyeva,Yenlik, AU - Lewis,Paige, AU - Shi,Jing, AU - Yue,Xin, AU - Museru,Oidda I, AU - Broder,Karen, Y1 - 2014/12/08/ PY - 2014/11/03/received PY - 2014/11/26/revised PY - 2014/11/27/accepted PY - 2014/12/16/entrez PY - 2014/12/17/pubmed PY - 2015/8/26/medline KW - Adverse events KW - Epidemiology KW - Pregnancy KW - Quadrivalent human papillomavirus vaccine KW - Surveillance KW - Vaccine safety SP - 519 EP - 22 JF - Vaccine JO - Vaccine VL - 33 IS - 4 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25500173/Safety_of_quadrivalent_human_papillomavirus_vaccine__Gardasil__in_pregnancy:_adverse_events_among_non_manufacturer_reports_in_the_Vaccine_Adverse_Event_Reporting_System_2006_2013_ DB - PRIME DP - Unbound Medicine ER -