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.

Abstract:

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. STUDY DESIGN: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. CONCLUSION: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.

journal_name

Am J Obstet Gynecol

authors

Moro PL,Broder K,Zheteyeva Y,Walton K,Rohan P,Sutherland A,Guh A,Haber P,Destefano F,Vellozzi C

doi

10.1016/j.ajog.2010.08.050

subject

Has Abstract

pub_date

2011-02-01 00:00:00

pages

146.e1-7

issue

2

eissn

0002-9378

issn

1097-6868

pii

S0002-9378(10)01105-1

journal_volume

204

pub_type

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