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Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women.
Am J Obstet Gynecol. 2014 Jun; 210(6):561.e1-6.AJ

Abstract

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.

Authors+Show Affiliations

Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD.Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24378675

Citation

Moro, Pedro L., et al. "Reports to the Vaccine Adverse Event Reporting System After Hepatitis a and Hepatitis AB Vaccines in Pregnant Women." American Journal of Obstetrics and Gynecology, vol. 210, no. 6, 2014, pp. 561.e1-6.
Moro PL, Museru OI, Niu M, et al. Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. Am J Obstet Gynecol. 2014;210(6):561.e1-6.
Moro, P. L., Museru, O. I., Niu, M., Lewis, P., & Broder, K. (2014). Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. American Journal of Obstetrics and Gynecology, 210(6), e1-6. https://doi.org/10.1016/j.ajog.2013.12.036
Moro PL, et al. Reports to the Vaccine Adverse Event Reporting System After Hepatitis a and Hepatitis AB Vaccines in Pregnant Women. Am J Obstet Gynecol. 2014;210(6):561.e1-6. PubMed PMID: 24378675.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. AU - Moro,Pedro L, AU - Museru,Oidda I, AU - Niu,Manette, AU - Lewis,Paige, AU - Broder,Karen, Y1 - 2013/12/27/ PY - 2013/09/16/received PY - 2013/11/20/revised PY - 2013/12/26/accepted PY - 2014/1/1/entrez PY - 2014/1/1/pubmed PY - 2014/7/16/medline KW - hepatitis A hepatitis B combined vaccine KW - hepatitis A vaccine KW - pregnancy KW - surveillance KW - vaccine safety SP - 561.e1 EP - 6 JF - American journal of obstetrics and gynecology JO - Am. J. Obstet. Gynecol. VL - 210 IS - 6 N2 - 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. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/24378675/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(13)02247-3 DB - PRIME DP - Unbound Medicine ER -