PMID- 27988883 OWN - NLM STAT- MEDLINE DCOM- 20171214 LR - 20190703 IS - 1179-1942 (Electronic) IS - 0114-5916 (Print) IS - 0114-5916 (Linking) VI - 40 IP - 2 DP - 2017 Feb TI - Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010-May 2016. PG - 145-152 LID - 10.1007/s40264-016-0482-1 [doi] AB - INTRODUCTION: Routine immunization of pregnant women with seasonal inactivated influenza vaccines (IIVs) is recommended in all trimesters of pregnancy. A review of the Vaccine Adverse Event Reporting System (VAERS) during 1990-2009 did not find any unexpected patterns of pregnancy complications or fetal outcomes after administration of IIV or live attenuated influenza vaccines (LAIVs). During the 2009-2010 pandemic influenza A (H1N1) vaccination campaign, a study noted that the number of VAERS reports from pregnant women who received the H1N1 2009 inactivated monovalent vaccine (n = 288) increased compared with 1990-2009 seasonal IIV pregnancy reports (n = 148). OBJECTIVES: The objective of this study was to assess the safety of seasonal influenza vaccines in pregnant women and their infants whose reports were submitted to VAERS during 2010-2016. METHODS: We searched VAERS for US reports of adverse events (AEs) in pregnant women who received IIV or LAIV from 1 July 2010 through 6 May 2016. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations. RESULTS: We identified 671 reports after seasonal influenza vaccines administered to pregnant women: 544 after IIV and 127 after LAIV. Serious events occurred among 61 (11.2%) reports following IIV and one (0.8%) report following LAIV. No deaths were reported. Among reports with trimester information (n = 296), IIV was administered during the first trimester in 116 (39.2%). Among IIV reports, the most frequent pregnancy-specific AE was spontaneous abortion in 62 (11.4%) reports, followed by stillbirth in ten (1.8%) and preterm delivery in six (1.1%). The most common non-pregnancy-specific AEs were injection-site reactions (55 [10.1%]). Neonatal or infant outcomes were reported in 22 (4.0%) reports, seven of which had major birth defects of different types and no neonatal deaths. CONCLUSION: As in 2009-2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. FAU - Moro, Pedro AU - Moro P AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd, MS D26, Atlanta, GA, 30329, USA. pmoro@cdc.gov. FAU - Baumblatt, Jane AU - Baumblatt J AD - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Lewis, Paige AU - Lewis P AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd, MS D26, Atlanta, GA, 30329, USA. FAU - Cragan, Janet AU - Cragan J AD - Birth Defects Branch, Division of Congenital and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities (NCBDDD), CDC, Atlanta, GA, USA. FAU - Tepper, Naomi AU - Tepper N AD - Women's Health and Fertility Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), CDC, Atlanta, GA, USA. FAU - Cano, Maria AU - Cano M AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd, MS D26, Atlanta, GA, 30329, USA. LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Comparative Study PT - Journal Article PL - New Zealand TA - Drug Saf JT - Drug safety JID - 9002928 RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Attenuated) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adolescent MH - Adult MH - *Adverse Drug Reaction Reporting Systems MH - Child MH - Female MH - Humans MH - Infant MH - Infant, Newborn MH - Influenza Vaccines/administration & dosage/*adverse effects MH - Influenza, Human/*prevention & control MH - Middle Aged MH - Pregnancy MH - *Pregnancy Outcome MH - Seasons MH - Vaccines, Attenuated/administration & dosage/adverse effects MH - Vaccines, Inactivated/administration & dosage/adverse effects MH - Young Adult PMC - PMC6602065 MID - NIHMS1025222 COIS- Conflict of interest: None of the authors have a conflict of interest. Part of this research was presented during the August 22-26, 2015 31st International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE). EDAT- 2016/12/19 06:00 MHDA- 2017/12/15 06:00 PMCR- 2019/07/01 CRDT- 2016/12/19 06:00 PHST- 2016/12/19 06:00 [pubmed] PHST- 2017/12/15 06:00 [medline] PHST- 2016/12/19 06:00 [entrez] PHST- 2019/07/01 00:00 [pmc-release] AID - 10.1007/s40264-016-0482-1 [pii] AID - 10.1007/s40264-016-0482-1 [doi] PST - ppublish SO - Drug Saf. 2017 Feb;40(2):145-152. doi: 10.1007/s40264-016-0482-1.