Evidence map›Paper›PMID 36335639›Full record

Trial reportEuropean journal of heart failure2023

Association of post-vaccination adverse reactions after influenza vaccine with mortality and cardiopulmonary outcomes in patients with high-risk cardiovascular disease: the INVESTED trial.

Alexander Peikert, Brian L Claggett, KyungMann Kim, Jacob A Udell, Jacob Joseph, Akshay S Desai, Michael E Farkouh, Sheila M Hegde, Adrian F Hernandez, Deepak L Bhatt and 8 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Update on clinical heart failure trials.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Review
  3. Article
  4. Review
  5. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 3 countries.

Alexander PeikertCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Brian L ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
KyungMann KimDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, USA.
Jacob A UdellPeter Munk Cardiac Centre, University Health Network and Women's College Hospital, University of Toronto, Toronto, ONT, Canada.
Jacob JosephCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Akshay S DesaiCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Michael E FarkouhPeter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, ONT, Canada.
Sheila M HegdeCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Adrian F HernandezDepartment of Medicine, Duke University, Durham, NC, USA.
Deepak L BhattCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
J Michael GazianoCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
H Keipp TalbotDepartment of Medicine, Vanderbilt University, Nashville, TN, USA.
Clyde YancyDepartment of Medicine, Northwestern University, Chicago, IL, USA.
Inder AnandDepartment of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA.
Lu MaoDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, USA.
Lawton S CooperNational Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Orly VardenyDepartment of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA.
Brigham and Women's Hospital · USHarvard University · USUniversity of Wisconsin–Madison · USDuke University · USMinneapolis VA Health Care System · USNational Heart Lung and Blood Institute · USNorthwestern University · PHUniversity Health Network · CAUniversity of Minnesota · USUniversity of Toronto · CAVanderbilt University · US

Funding

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)U01HL130163 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SOLOMON, SCOTT DAVID, VARDENY, ORLY · 2016 to 2019
$19.1M
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)-Data Coordinating CenterU01HL130204 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI KIM, KYUNGMANN · 2016 to 2020
$1.9M
NHLBI NIH HHS U01 HL130163NHLBI NIH HHS U01HL130163NHLBI NIH HHS U01 HL130204NHLBI NIH HHS U01HL130204
6 · The paper itself

Abstract

aimsInfluenza vaccination is associated with reduced cardiopulmonary morbidity and mortality among patients with heart failure or recent myocardial infarction. The immune response to vaccination frequently results in mild adverse reactions (AR), which leads to vaccine hesitancy. This post hoc analysis explored the association between vaccine-related AR and morbidity and mortality in patients with high-risk cardiovascular disease. METHODS AND

resultsThe INVESTED trial randomized 5260 patients with recent heart failure hospitalization or acute myocardial infarction to high-dose trivalent or standard-dose quadrivalent inactivated influenza vaccine. We examined the association between vaccine-related AR and adverse clinical outcomes across both treatment groups in propensity-adjusted models. Among 5210 participants with available information on post-vaccination symptoms, 1968 participants (37.8%) experienced a vaccine-related AR. Compared to those without AR, post-vaccination AR, most commonly injection site pain (60.3%), were associated with lower risk for the composite of all-cause death or cardiopulmonary hospitalization (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.75-0.92, p < 0.001), cardiopulmonary hospitalizations (HR 0.85 [95% CI 0.76-0.95], p = 0.003), all-cause death (HR 0.77 [95% CI 0.62-0.96], p = 0.02), cardiovascular hospitalizations (HR 0.88 [95% CI 0.78-0.99], p = 0.03) and non-cardiopulmonary hospitalizations (HR 0.80 [95% CI 0.69-0.92], p = 0.003). While mild (76.4%) and moderate (20.6%) AR were most common and together associated with lower risk for the primary outcome (HR 0.81 [95% CI 0.74-0.90], p < 0.001), severe AR (2.9%) were related to increased risk (HR 1.68 [95% CI 1.17-2.42], p = 0.005).

conclusionMild to moderate post-vaccination reactions after influenza vaccine were associated with reduced risk of cardiopulmonary hospitalizations and all-cause mortality in patients with high-risk cardiovascular disease, while severe reactions may indicate increased risk. Mild to moderate AR to influenza vaccination may be a marker of immune response and should not deter future vaccinations.

Indexed as

Cardiovascular DiseasesHeart FailureInfluenza, HumanInfluenza VaccinesHumansVaccinationInfluenza VaccinesAll-cause deathCardiopulmonary hospitalizationsHigh-risk cardiovascular diseaseInfluenza vaccinePost-vaccination adverse reactions

Identifiers

PMID36335639
PMCPMC10292027
OpenAlexW4308294967

What OpenQuestion holds

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Registered trials

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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.