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Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women.
Am J Obstet Gynecol. 2012 Jul; 207(1):59.e1-7.AJ

Abstract

OBJECTIVE

We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap).

STUDY DESIGN

We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records.

RESULTS

We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified.

CONCLUSION

During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

22727350

Citation

Zheteyeva, Yenlik A., et al. "Adverse Event Reports After Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines in Pregnant Women." American Journal of Obstetrics and Gynecology, vol. 207, no. 1, 2012, pp. 59.e1-7.
Zheteyeva YA, Moro PL, Tepper NK, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol. 2012;207(1):59.e1-7.
Zheteyeva, Y. A., Moro, P. L., Tepper, N. K., Rasmussen, S. A., Barash, F. E., Revzina, N. V., Kissin, D., Lewis, P. W., Yue, X., Haber, P., Tokars, J. I., Vellozzi, C., & Broder, K. R. (2012). Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. American Journal of Obstetrics and Gynecology, 207(1), e1-7. https://doi.org/10.1016/j.ajog.2012.05.006
Zheteyeva YA, et al. Adverse Event Reports After Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines in Pregnant Women. Am J Obstet Gynecol. 2012;207(1):59.e1-7. PubMed PMID: 22727350.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. AU - Zheteyeva,Yenlik A, AU - Moro,Pedro L, AU - Tepper,Naomi K, AU - Rasmussen,Sonja A, AU - Barash,Faith E, AU - Revzina,Natalia V, AU - Kissin,Dmitry, AU - Lewis,Paige W, AU - Yue,Xin, AU - Haber,Penina, AU - Tokars,Jerome I, AU - Vellozzi,Claudia, AU - Broder,Karen R, Y1 - 2012/05/14/ PY - 2012/02/17/received PY - 2012/03/29/revised PY - 2012/05/09/accepted PY - 2012/6/26/entrez PY - 2012/6/26/pubmed PY - 2012/8/28/medline SP - 59.e1 EP - 7 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 207 IS - 1 N2 - OBJECTIVE: We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). STUDY DESIGN: We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records. RESULTS: We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified. CONCLUSION: During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/22727350/Adverse_event_reports_after_tetanus_toxoid_reduced_diphtheria_toxoid_and_acellular_pertussis_vaccines_in_pregnant_women_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(12)00504-2 DB - PRIME DP - Unbound Medicine ER -