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Reports to the Vaccine Adverse Event Reporting System (VAERS) after Hepatitis A and Hepatitis AB Vaccines in Pregnant women
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6 2014
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Source: Am J Obstet Gynecol. 210(6):561.e1-561.e6
[PDF-74.45 KB]
Details:
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Alternative Title:Am J Obstet Gynecol
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Personal Author:
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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.
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Pubmed ID:24378675
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Pubmed Central ID:PMC6500450
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Funding:
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Volume:210
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Issue:6
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