Evidence map›Paper›PMID 41016231›Full record

ArticleVaccine2025

Clinical immunization safety assessment (CISA) project: COVID-19 vaccine consultations and case reviews.

Paula M Campbell, Gabriella J Ess, Allison Lale, Kawsar R Talaat, Elizabeth D Barnett, Stephen I Pelton, Elizabeth P Schlaudecker, Mary Staat, Melissa S Stockwell, Phillip S LaRussa and 13 more

Abstract read
In one paragraph

Article in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Paula M CampbellDivision of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, United States.
Gabriella J EssEmory University, Atlanta, GA, United States.
Allison LaleCenters for Disease Control and Prevention, Atlanta, GA, United States.
Kawsar R TalaatJohns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
Elizabeth D BarnettDepartment of Pediatrics, Section of Pediatric Infectious Diseases, Boston Medical Center, and BU Chobanian & Avedisian School of Medicine, Boston, MA, United States.
Stephen I PeltonDepartment of Pediatrics, Section of Pediatric Infectious Diseases, Boston Medical Center, and BU Chobanian & Avedisian School of Medicine, Boston, MA, United States.
Elizabeth P SchlaudeckerDepartment of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, United States.
Mary StaatDepartment of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, United States.
Melissa S StockwellColumbia University Irving Medical Center, New York, NY, United States.
Phillip S LaRussaColumbia University Irving Medical Center, New York, NY, United States.
Emmanuel B WalterDuke University School of Medicine, Durham, NC, United States.
Michael J SmithDuke University School of Medicine, Durham, NC, United States.
Neal A HalseyJohns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
Nicola P KleinVaccine Study Center, Northern California Kaiser Permanente Division of Research, Oakland, CA, United States.
Michael M McNeilCenters for Disease Control and Prevention, Atlanta, GA, United States.
Karen R BroderCenters for Disease Control and Prevention, Atlanta, GA, United States.
Tom T ShimabukuroCenters for Disease Control and Prevention, Atlanta, GA, United States.
Matthew B CristCenters for Disease Control and Prevention, Atlanta, GA, United States.
Tarayn A FairlieCenters for Disease Control and Prevention, Atlanta, GA, United States.
Shashi SharmaCenters for Disease Control and Prevention, Atlanta, GA, United States.
C Buddy CreechDivision of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, United States. Electronic address: buddy.creech@vumc.org.
Kathryn M EdwardsDivision of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, United States. Electronic address: kathryn.edwards@vumc.org.
CISA Project Team

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
NCATS NIH HHS UL1 TR000445Wellcome Trust
6 · The paper itself

Abstract

backgroundThe Clinical Immunization Safety Assessment (CISA) Project is a network of vaccine safety experts from the Centers for Disease Control and Prevention (CDC) Immunization Safety Office (ISO) and seven medical research centers. CISA responds to inquiries from U.S. healthcare providers (HCPs) and conducts vaccine safety research. This report summarizes the CISA approach to addressing provider vaccine safety inquiries during the COVID-19 pandemic and describes these consultations.

methodsDuring the COVID-19 pandemic, CDC established a 24/7 on-call CISA consultation service. Inquiries were reviewed, and some of the most clinically complex were selected for comprehensive, structured CISA clinical case consultations. After confidential consultations, provider satisfaction surveys were sent, and providers were queried about patient outcomes and whether patients tolerated subsequent COVID-19 vaccinations.

resultsFrom December 14, 2020, through December 31, 2022, CDC staff and CISA investigators conducted 79 comprehensive clinical case consultations (73 regarding adverse events following immunization (AEFI) after COVID-19 vaccine, and 6 pre-vaccination questions). Of the 73 AEFI consultations, 31 (42 %) included neurologic and 14 (19 %) allergic or hypersensitivity symptoms. Cardiology and hematology inquiries comprised most of the remainder. Twenty-four (30 %) provider satisfaction surveys were returned; all respondents found the service helpful. Of 38 (79 total; 48 %) returned patient follow-up surveys, 14 (37 %) reported that subsequent COVID-19 vaccines were administered and were well-tolerated in case patients. DISCUSSION: Despite low participation rate in satisfaction and patient follow-up surveys, the CISA consultation service provided timely COVID-19 vaccine safety evaluations for HCPs through comprehensive clinical case consultations and vaccine safety guidance, a unique role in the pandemic response.

Indexed as

COVID-19COVID-19 VaccinesImmunizationReferral and ConsultationAdultCenters for Disease Control and Prevention, U.S.FemaleHealth PersonnelHumansMaleMiddle AgedSARS-CoV-2Surveys and QuestionnairesUnited StatesVaccinationCOVID-19 VaccinesAdverse event following immunizationClinical immunization safety assessment (CISA) projectCOVID-19 vaccineVaccine safety

Identifiers

PMID41016231
PMCPMC13378602

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.