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.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to American Journal of Obstetrics & GynecologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Delivering influenza vaccine to pregnant women.Epidemiol Rev. 2006; 28: 47-53
- Pandemic influenza and pregnant women.Emerg Infect Diseases. 2008; 14: 95-100
- H1N1 2009 influenza virus infection during pregnancy in the USA.Lancet. 2009; 374: 451-458
- Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women.CMAJ. 2007; 176: 463-468
- Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women.Am J Epidemiol. 1998; 148: 1094-1102
- Is routine influenza immunization warranted in early pregnancy?.Vaccine. 2009; 27: 4754-4770
- Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009.MMWR Recomm Rep. 2009; 58: 1-52
- Pregnant women's knowledge of influenza and the use and safety of the influenza vaccine during pregnancy.J Obstet Gynaecol Can. 2009; 31: 120-125
- Obstetric health care workers' attitudes and beliefs regarding influenza vaccination in pregnancy.Obstet Gynecol. 2009; 114: 981-987
- Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring.Vaccine. 2009; 27: 2114-2120
- Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6-23 months of age.Vaccine. 2009; 27: 4278-4283
- Understanding vaccine safety information from the Vaccine Adverse Event Reporting System.Pediatr Infect Dis J. 2004; 23: 287-294
- 21 CFR Part 600.80.Federal Register. 1997; 62: 52252-52253
- Medical Dictionary for Regulatory Activities.(Accessed Aug. 24, 2009)
- The development of standardized case definitions and guidelines for adverse events following immunization.Vaccine. 2007; 25: 5671-5674
- Estimated pregnancy rates by outcome for the United States, 1990–2004.Natl Vital Stat Rep. 2008; 56 (Accessed Aug. 24, 2009): 1-28
- Influenza vaccination of recommended adult populations, United States, 1989-2005.Vaccine. 2008; 26: 1786-1793
- The Brighton Collaboration: definitions and guidelines.(Accessed June 1, 2010)
- Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data.Vaccine. 2007; 25: 5675-5684
- Importance of background rates of disease in assessment of vaccine safety during mass immunization with pandemic H1N1 influenza vaccines.Lancet. 2009; 374: 2115-2122
- Influenza vaccination in pregnancy.Am J Perinatol. 1999; 16: 283-286
- A/NJ/8/76 influenza vaccination program: effects on maternal health and pregnancy outcome.Am J Obstet Gynecol. 1981; 140: 240-245
- Bell's palsy and tinnitus during pregnancy: predictors of preeclampsia: three cases and a detailed review of the literature.Acta Otolaryngologica. 1999; 119: 647-651
- A potential signal of Bell's palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)—United States, 1991-2001.Pharmacoepidemiol Drug Saf. 2004; 13: 505-510
- Immunization safety review: influenza vaccines and neurological complications.National Academy Press, Washington, DC2004
- Bell's palsy and parenteral inactivated influenza vaccine.Hum Vaccine. 2006; 2: 110-112
- Safety of influenza vaccination during pregnancy.Am J Obstet Gynecol. 2009; 201: 547-552
- Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy.Int J Epidemiol. 1973; 2: 229-235
- Safety of influenza vaccination during pregnancy.Am J Obstet Gynecol. 2005; 192: 1098-1106
- Safety of influenza A (H1N1) 2009 monovalent vaccines—United States, October 1-November 24, 2009.MMWR Morb Mortal Wkly Rep. 2009; 58: 1-6
Article info
Publication history
Published online: October 21, 2010
Accepted:
August 30,
2010
Received in revised form:
August 13,
2010
Received:
June 8,
2010
Footnotes
Cite this article as: Moro PL, Broder K, Zheteyeva Y, et al. 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. Am J Obstet Gynecol 2011;204:146.e1-7.
Identification
Copyright
Published by Elsevier Inc.
