PMID- 21861964 OWN - NLM STAT- MEDLINE DCOM- 20120117 LR - 20231012 IS - 1097-6868 (Electronic) IS - 0002-9378 (Print) IS - 0002-9378 (Linking) VI - 205 IP - 5 DP - 2011 Nov TI - Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System. PG - 473.e1-9 LID - 10.1016/j.ajog.2011.06.047 [doi] AB - OBJECTIVE: The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems. STUDY DESIGN: We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010. RESULTS: VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks); 18 stillbirths (>/=20 weeks); 7 preterm deliveries (<37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip. CONCLUSION: Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes. CI - Published by Mosby, Inc. FAU - Moro, Pedro L AU - Moro PL AD - 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. pmoro@cdc.gov FAU - Broder, Karen AU - Broder K FAU - Zheteyeva, Yenlik AU - Zheteyeva Y FAU - Revzina, Natalya AU - Revzina N FAU - Tepper, Naomi AU - Tepper N FAU - Kissin, Dmitry AU - Kissin D FAU - Barash, Faith AU - Barash F FAU - Arana, Jorge AU - Arana J FAU - Brantley, Mary D AU - Brantley MD FAU - Ding, Helen AU - Ding H FAU - Singleton, James A AU - Singleton JA FAU - Walton, Kimp AU - Walton K FAU - Haber, Penina AU - Haber P FAU - Lewis, Paige AU - Lewis P FAU - Yue, Xin AU - Yue X FAU - Destefano, Frank AU - Destefano F FAU - Vellozzi, Claudia AU - Vellozzi C LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Journal Article DEP - 20110621 PL - United States TA - Am J Obstet Gynecol JT - American journal of obstetrics and gynecology JID - 0370476 RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Attenuated) SB - IM MH - Adverse Drug Reaction Reporting Systems MH - Female MH - Humans MH - Influenza A Virus, H1N1 Subtype/*immunology MH - Influenza Vaccines/*adverse effects MH - Influenza, Human/immunology/*prevention & control MH - Patient Safety MH - Pregnancy MH - Vaccines, Attenuated/adverse effects PMC - PMC6602056 MID - NIHMS1025602 EDAT- 2011/08/25 06:00 MHDA- 2012/01/18 06:00 PMCR- 2019/07/01 CRDT- 2011/08/25 06:00 PHST- 2010/12/03 00:00 [received] PHST- 2011/04/11 00:00 [revised] PHST- 2011/06/09 00:00 [accepted] PHST- 2011/08/25 06:00 [entrez] PHST- 2011/08/25 06:00 [pubmed] PHST- 2012/01/18 06:00 [medline] PHST- 2019/07/01 00:00 [pmc-release] AID - S0002-9378(11)00775-7 [pii] AID - 10.1016/j.ajog.2011.06.047 [doi] PST - ppublish SO - Am J Obstet Gynecol. 2011 Nov;205(5):473.e1-9. doi: 10.1016/j.ajog.2011.06.047. Epub 2011 Jun 21.