PMID- 30660400
OWN - NLM
STAT- MEDLINE
DCOM- 20200727
LR  - 20210109
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 37
IP  - 9
DP  - 2019 Feb 21
TI  - Safety of 9-valent human papillomavirus vaccine administration among pregnant 
      women: Adverse event reports in the Vaccine Adverse Event Reporting System 
      (VAERS), 2014-2017.
PG  - 1229-1234
LID - S0264-410X(18)31641-4 [pii]
LID - 10.1016/j.vaccine.2018.11.077 [doi]
AB  - 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.
CI  - Copyright (c) 2018 Elsevier Ltd. All rights reserved.
FAU - Landazabal, Claudia S
AU  - Landazabal CS
AD  - Emory University Rollins School of Public Health, Department of Epidemiology, 
      1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: 
      claudialandazabal@alumni.emory.edu.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - 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.
FAU - Lewis, Paige
AU  - Lewis P
AD  - 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.
FAU - Omer, Saad B
AU  - Omer SB
AD  - 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.
LA  - eng
GR  - CC999999/ImCDC/Intramural CDC HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20190116
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Child
MH  - Databases, Factual/*statistics & numerical data
MH  - Epidemiological Monitoring
MH  - Female
MH  - Humans
MH  - Injection Site Reaction
MH  - Papillomavirus Vaccines/*adverse effects
MH  - Pregnancy
MH  - *Pregnant Women
MH  - Product Surveillance, Postmarketing
MH  - United States
MH  - United States Food and Drug Administration
MH  - Vaccination/*adverse effects
MH  - Young Adult
PMC - PMC6505695
MID - NIHMS1023485
OTO - NOTNLM
OT  - Adverse event
OT  - Epidemiology
OT  - Human papillomavirus vaccine
OT  - Surveillance
OT  - Vaccine safety
EDAT- 2019/01/21 06:00
MHDA- 2020/07/28 06:00
PMCR- 2019/11/21
CRDT- 2019/01/21 06:00
PHST- 2018/09/01 00:00 [received]
PHST- 2018/11/09 00:00 [revised]
PHST- 2018/11/30 00:00 [accepted]
PHST- 2019/01/21 06:00 [pubmed]
PHST- 2020/07/28 06:00 [medline]
PHST- 2019/01/21 06:00 [entrez]
PHST- 2019/11/21 00:00 [pmc-release]
AID - S0264-410X(18)31641-4 [pii]
AID - 10.1016/j.vaccine.2018.11.077 [doi]
PST - ppublish
SO  - Vaccine. 2019 Feb 21;37(9):1229-1234. doi: 10.1016/j.vaccine.2018.11.077. Epub 
      2019 Jan 16.