Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009.
OBJECTIVE
The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns.


METHODS
We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009.


RESULTS
A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated.


CONCLUSIONS
No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV.
Immunization Safety Office, Division of Healthcare Quality Promotion/National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Pedro L
PL
Moro
Karen
K
Broder
Yenlik
Y
Zheteyeva
Kimp
K
Walton
Patricia
P
Rohan
Andrea
A
Sutherland
Alice
A
Guh
Penina
P
Haber
Frank
F
Destefano
Claudia
C
Vellozzi
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D015994:Incidence; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D009975:Orthomyxoviridae / Q000276:immunology*; D011247:Pregnancy; D014613:Vaccines, Attenuated / Q000009:adverse effects
D007252:Influenza Vaccines; D014613:Vaccines, Attenuated