ArticleDrug safety2017
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.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Maternal influenza vaccination during the first trimester of pregnancy and risk for birth defects: an updated systematic review and meta-analysis.BMC pregnancy and childbirth · 2026Pooled it
- Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis.PloS one · 2020Pooled it
- The safety of inactivated influenza vaccines in pregnancy for birth outcomes: a systematic review.Human vaccines & immunotherapeutics · 2019Pooled it
- The Impact of Maternal Influenza Infection and Vaccination During Pregnancy on Birth Outcomes.The Pediatric infectious disease journal · 2026Article
- Avian Influenza H5N1 Infection During Pregnancy: Preparing for the Next Flu Pandemic and Improving Perinatal Outcomes.Viruses · 2026Review
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- Article
- Do Pregnant Persons Want Influenza Vaccines? Knowledge, Attitudes, Perceptions, and Practices Toward Influenza Vaccines in 8 Low- and Middle-Income Countries.The Journal of infectious diseases · 2025Article
- Article
- Vaccination coverage during pregnancy and factors associated with refusal of recommended vaccinations: An Italian cross sectional study.Vaccine: X · 2024Article
- Maternal vaccination-current status, challenges, and opportunities.The journal of obstetrics and gynaecology research · 2023Review
- Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry.Influenza and other respiratory viruses · 2022Article
- Prevalence of and factors associated with receipt of provider recommendation for influenza vaccination and uptake of influenza vaccination during pregnancy: cross-sectional study.BMC pregnancy and childbirth · 2021Article
- Seasonal influenza vaccine uptake and vaccine refusal among pregnant women in France: results from a national survey.Human vaccines & immunotherapeutics · 2020Article
- The Importance of Vaccinating Children and Pregnant Women against Influenza Virus Infection.Pathogens (Basel, Switzerland) · 2019Review
- Host Factors Impact Vaccine Efficacy: Implications for Seasonal and Universal Influenza Vaccine Programs.Journal of virology · 2019Review
- Influenza immunization policies: Which could be the main reasons for differences among countries?Human vaccines & immunotherapeutics · 2018Review
- Article
- Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.Vaccine · 2017Article
- Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12.Vaccine · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
Abstract
introductionRoutine 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).
objectivesThe 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.
methodsWe 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.
resultsWe 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.
conclusionAs in 2009-2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.