PMID- 25500173
OWN - NLM
STAT- MEDLINE
DCOM- 20150825
LR  - 20200225
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 33
IP  - 4
DP  - 2015 Jan 15
TI  - Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: 
      adverse events among non-manufacturer reports in the Vaccine Adverse Event 
      Reporting System, 2006-2013.
PG  - 519-22
LID - S0264-410X(14)01604-1 [pii]
LID - 10.1016/j.vaccine.2014.11.047 [doi]
AB  - 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.
CI  - Published by Elsevier Ltd.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - 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.
FAU - Zheteyeva, Yenlik
AU  - Zheteyeva Y
AD  - Community Interventions for Infection Control Unit, Division of Global Migration 
      and Quarantine, Centers for Disease Control and Prevention (CDC), United States.
FAU - Lewis, Paige
AU  - Lewis P
AD  - 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.
FAU - Shi, Jing
AU  - Shi J
AD  - 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.
FAU - Yue, Xin
AU  - Yue X
AD  - Assessment Branch, Immunization Services Division, National Center for 
      Immunization and Respiratory Diseases, CDC, United States.
FAU - Museru, Oidda I
AU  - Museru OI
AD  - 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.
FAU - Broder, Karen
AU  - Broder K
AD  - 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.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20141208
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18)
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Female
MH  - Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
MH  - Humans
MH  - Infant, Newborn
MH  - Papillomavirus Infections/*prevention & control
MH  - Papillomavirus Vaccines/administration & dosage/*adverse effects
MH  - Pregnancy
MH  - Pregnancy Outcome
MH  - Young Adult
PMC - PMC6524774
MID - NIHMS1025273
OTO - NOTNLM
OT  - Adverse events
OT  - Epidemiology
OT  - Pregnancy
OT  - Quadrivalent human papillomavirus vaccine
OT  - Surveillance
OT  - Vaccine safety
EDAT- 2014/12/17 06:00
MHDA- 2015/08/26 06:00
PMCR- 2019/05/17
CRDT- 2014/12/16 06:00
PHST- 2014/11/03 00:00 [received]
PHST- 2014/11/26 00:00 [revised]
PHST- 2014/11/27 00:00 [accepted]
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2015/08/26 06:00 [medline]
PHST- 2019/05/17 00:00 [pmc-release]
AID - S0264-410X(14)01604-1 [pii]
AID - 10.1016/j.vaccine.2014.11.047 [doi]
PST - ppublish
SO  - Vaccine. 2015 Jan 15;33(4):519-22. doi: 10.1016/j.vaccine.2014.11.047. Epub 2014 
      Dec 8.