Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women.
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).


METHODS
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.


CONCLUSIONS
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.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA.
Yenlik A
YA
Zheteyeva
Pedro L
PL
Moro
Naomi K
NK
Tepper
Sonja A
SA
Rasmussen
Faith E
FE
Barash
Natalia V
NV
Revzina
Dmitry
D
Kissin
Paige W
PW
Lewis
Xin
X
Yue
Penina
P
Haber
Jerome I
JI
Tokars
Claudia
C
Vellozzi
Karen R
KR
Broder
D000022:Abortion, Spontaneous / Q000209:etiology; D000293:Adolescent; D000328:Adult; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology*; D011358:Product Surveillance, Postmarketing; D014481:United States; D055815:Young Adult
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines