PMID- 29174107
OWN - NLM
STAT- MEDLINE
DCOM- 20180731
LR  - 20200225
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 36
IP  - 1
DP  - 2018 Jan 2
TI  - Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine 
      Adverse Event Reporting System (VAERS), 1990-2016.
PG  - 50-54
LID - S0264-410X(17)31603-1 [pii]
LID - 10.1016/j.vaccine.2017.11.039 [doi]
AB  - BACKGROUND: The safety of hepatitis B vaccination during pregnancy has not been 
      well studied. OBJECTIVE: We characterized adverse events (AEs) after hepatitis B 
      vaccination of pregnant women reported to the Vaccine Adverse Event Reporting 
      System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched 
      VAERS for AEs reports involving pregnant women who received hepatitis B vaccine 
      from January 1, 1990-June 30, 2016. All reports and available medical records 
      were reviewed by physicians. Observed AEs were compared to expected AEs and known 
      rates of pregnancy outcomes to assess for any unexpected safety concern. RESULTS: 
      We found 192 reports involving pregnant women following hepatitis B vaccination 
      of which 110 (57.3%) described AEs; 12 (6.3%) were classified as serious; one 
      newborn death was identified in a severely premature delivery, and there were no 
      maternal deaths. Eighty-two (42.7%) reports did not describe any AEs. Among 
      pregnancies for which gestational age was reported, most women were vaccinated 
      during the first trimester, 86/115 (74.7%). Among reports describing an AE, the 
      most common pregnancy-specific outcomes included spontaneous abortion in 23 
      reports, preterm delivery in 7 reports, and elective termination in 5 reports. 
      The most common non-pregnancy specific outcomes were general disorders and 
      administration site conditions, such as injection site and systemic reactions, in 
      21 reports. Among 22 reports describing an AE among infants born to women 
      vaccinated during pregnancy, 5 described major birth defects each affecting 
      different organ systems. CONCLUSION: Our analysis of VAERS reports involving 
      hepatitis B vaccination during pregnancy did not identify any new or unexpected 
      safety concerns.
CI  - Published by Elsevier Ltd.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office (ISO), 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: 
      plmoro@yahoo.com.
FAU - Zheteyeva, Yenlik
AU  - Zheteyeva Y
AD  - Community Interventions for Infection Control Unit, Division of Global Migration 
      and Quarantine, NCEZID, CDC, United States.
FAU - Barash, Faith
AU  - Barash F
AD  - Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), 
      United States.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office (ISO), Division of Healthcare Quality Promotion, 
      National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
      for Disease Control and Prevention (CDC), United States.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office (ISO), 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
DEP - 20171127
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Hepatitis B Vaccines)
SB  - IM
MH  - Abortion, Spontaneous/etiology
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Congenital Abnormalities/etiology
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Epidemiological Monitoring
MH  - Female
MH  - Gestational Age
MH  - Hepatitis B/epidemiology/*prevention & control/virology
MH  - Hepatitis B Vaccines/administration & dosage/*adverse effects
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Medical Records
MH  - Pregnancy
MH  - Pregnancy Outcome/epidemiology
MH  - Premature Birth/etiology
MH  - United States/epidemiology
MH  - Vaccination/*adverse effects/statistics & numerical data
MH  - Young Adult
PMC - PMC6626541
MID - NIHMS1023496
OTO - NOTNLM
OT  - Adverse event
OT  - Epidemiology
OT  - Hepatitis B vaccine
OT  - Surveillance
OT  - Vaccine safety
COIS- Disclosures: No authors have a conflict of interest, including specific financial 
      interests and relationships and affiliations relevant to the subject matter or 
      materials discussed in the manuscript.
EDAT- 2017/11/28 06:00
MHDA- 2018/08/01 06:00
PMCR- 2019/07/13
CRDT- 2017/11/28 06:00
PHST- 2017/06/25 00:00 [received]
PHST- 2017/11/13 00:00 [revised]
PHST- 2017/11/14 00:00 [accepted]
PHST- 2017/11/28 06:00 [pubmed]
PHST- 2018/08/01 06:00 [medline]
PHST- 2017/11/28 06:00 [entrez]
PHST- 2019/07/13 00:00 [pmc-release]
AID - S0264-410X(17)31603-1 [pii]
AID - 10.1016/j.vaccine.2017.11.039 [doi]
PST - ppublish
SO  - Vaccine. 2018 Jan 2;36(1):50-54. doi: 10.1016/j.vaccine.2017.11.039. Epub 2017 
      Nov 27.