Reports to the Vaccine Adverse Event Reporting System (VAERS) after Hepatitis A and Hepatitis AB Vaccines in Pregnant women

Details

• Alternative Title:
  Am J Obstet Gynecol
• Personal Author:
  MORO, Pedro L. ; MUSERU, Oidda I. ; NIU, Manette ; LEWIS, Paige ; BRODER, Karen
• Description:
  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 01/01/1996-04/05/2013. 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 an AE. 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 pre-term delivery in 7 (5.0%) reports. The most common non-pregnancy 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.
  
  Conclusions:
  
  This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal HepA or HepAB immunizations during pregnancy.
  
  
• Subjects:
  Abortion, Spontaneous Adult Adverse Drug Reaction Reporting Systems Female Hepatitis A Hepatitis B Humans Infant, Newborn Pregnancy Premature Birth United States Urinary Tract Infections Viral Hepatitis Vaccines

  More +
• Keywords:
  Hepatitis A Hepatitis B Combined Vaccine Hepatitis A Vaccine Pregnancy Surveillance Vaccine Safety
• Source:
  Am J Obstet Gynecol. 210(6):561.e1-561.e6
• Pubmed ID:
  24378675
• Pubmed Central ID:
  PMC6500450
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHSUnited States/
• Volume:
  210
• Issue:
  6
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:f0e43348ac26df42430ed64aac42559f5fc0c1626d895087058e3589a1cfb0fda8f61717bf726665f1b2e6e894fc5b02369a54d72885f0f8fb0bb500c2eee88d
• Download URL:
  https://stacks.cdc.gov/view/cdc/78341/cdc_78341_DS1.pdf
• File Type:
  [PDF - 74.45 KB ]