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Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016.
Vaccine. 2018 01 02; 36(1):50-54.V

Abstract

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.

Authors+Show Affiliations

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.Community Interventions for Infection Control Unit, Division of Global Migration and Quarantine, NCEZID, CDC, United States.Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), United States.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.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.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29174107

Citation

Moro, Pedro L., et al. "Assessing the Safety of Hepatitis B Vaccination During Pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016." Vaccine, vol. 36, no. 1, 2018, pp. 50-54.
Moro PL, Zheteyeva Y, Barash F, et al. Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. Vaccine. 2018;36(1):50-54.
Moro, P. L., Zheteyeva, Y., Barash, F., Lewis, P., & Cano, M. (2018). Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. Vaccine, 36(1), 50-54. https://doi.org/10.1016/j.vaccine.2017.11.039
Moro PL, et al. Assessing the Safety of Hepatitis B Vaccination During Pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. Vaccine. 2018 01 2;36(1):50-54. PubMed PMID: 29174107.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. AU - Moro,Pedro L, AU - Zheteyeva,Yenlik, AU - Barash,Faith, AU - Lewis,Paige, AU - Cano,Maria, Y1 - 2017/11/27/ PY - 2017/06/25/received PY - 2017/11/13/revised PY - 2017/11/14/accepted PY - 2017/11/28/pubmed PY - 2018/8/1/medline PY - 2017/11/28/entrez KW - Adverse event KW - Epidemiology KW - Hepatitis B vaccine KW - Surveillance KW - Vaccine safety SP - 50 EP - 54 JF - Vaccine JO - Vaccine VL - 36 IS - 1 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29174107/Assessing_the_safety_of_hepatitis_B_vaccination_during_pregnancy_in_the_Vaccine_Adverse_Event_Reporting_System__VAERS__1990_2016_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)31603-1 DB - PRIME DP - Unbound Medicine ER -