PMID- 24378675
OWN - NLM
STAT- MEDLINE
DCOM- 20140715
LR  - 20231011
IS  - 1097-6868 (Electronic)
IS  - 0002-9378 (Print)
IS  - 0002-9378 (Linking)
VI  - 210
IP  - 6
DP  - 2014 Jun
TI  - Reports to the Vaccine Adverse Event Reporting System after hepatitis A and 
      hepatitis AB vaccines in pregnant women.
PG  - 561.e1-6
LID - S0002-9378(13)02247-3 [pii]
LID - 10.1016/j.ajog.2013.12.036 [doi]
AB  - OBJECTIVE: To characterize adverse events (AEs) after hepatitis A vaccines (Hep 
      A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women 
      reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous 
      reporting surveillance system. STUDY DESIGN: We searched VAERS for AEs reports in 
      pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. 
      Clinicians reviewed all reports and available medical records. RESULTS: VAERS 
      received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; no maternal 
      or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. 
      For those women whose gestational age was available, most were vaccinated during 
      the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The 
      most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations 
      were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 
      (7.2%), and preterm delivery in 7 (5.0%) reports. The most common nonpregnancy 
      specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) 
      reports each. One case of amelia of the lower extremities was reported in an 
      infant following maternal Hep A immunization. CONCLUSION: This review of VAERS 
      reports did not identify any concerning pattern of AEs in pregnant women or their 
      infants following maternal Hep A or Hep AB immunizations during pregnancy.
CI  - Published by Mosby, Inc.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, Atlanta, GA.
FAU - Museru, Oidda I
AU  - Museru OI
AD  - Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, Atlanta, GA.
FAU - Niu, Manette
AU  - Niu M
AD  - Center for Biologics Evaluation and Research, US Food and Drug Administration, 
      Rockville, MD.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, Atlanta, GA.
FAU - Broder, Karen
AU  - Broder K
AD  - Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, Atlanta, GA.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
DEP - 20131227
PL  - United States
TA  - Am J Obstet Gynecol
JT  - American journal of obstetrics and gynecology
JID - 0370476
RN  - 0 (Viral Hepatitis Vaccines)
SB  - IM
MH  - Abortion, Spontaneous/epidemiology
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Female
MH  - Hepatitis A/*immunology
MH  - Hepatitis B/*immunology
MH  - Humans
MH  - Infant, Newborn
MH  - Pregnancy
MH  - Premature Birth/epidemiology
MH  - United States/epidemiology
MH  - Urinary Tract Infections/epidemiology
MH  - Viral Hepatitis Vaccines/*adverse effects
PMC - PMC6500450
MID - NIHMS1025291
OTO - NOTNLM
OT  - hepatitis A hepatitis B combined vaccine
OT  - hepatitis A vaccine
OT  - pregnancy
OT  - surveillance
OT  - vaccine safety
COIS- Disclosure: the authors report no conflict of interest
EDAT- 2014/01/01 06:00
MHDA- 2014/07/16 06:00
PMCR- 2019/05/04
CRDT- 2014/01/01 06:00
PHST- 2013/09/16 00:00 [received]
PHST- 2013/11/20 00:00 [revised]
PHST- 2013/12/26 00:00 [accepted]
PHST- 2014/01/01 06:00 [entrez]
PHST- 2014/01/01 06:00 [pubmed]
PHST- 2014/07/16 06:00 [medline]
PHST- 2019/05/04 00:00 [pmc-release]
AID - S0002-9378(13)02247-3 [pii]
AID - 10.1016/j.ajog.2013.12.036 [doi]
PST - ppublish
SO  - Am J Obstet Gynecol. 2014 Jun;210(6):561.e1-6. doi: 10.1016/j.ajog.2013.12.036. 
      Epub 2013 Dec 27.