Evidence map›Paper›PMID 36108922›Full record

ArticleThe journal of allergy and clinical immunology. In practice2023

Clinical Phenotypes of Immediate First-Dose Reactions to mRNA COVID-19: A Multicenter Latent Class Analysis.

Cosby A Stone, Lacey B Robinson, Lily Li, Matthew S Krantz, Jason H Kwah, Gilbert Ortega, Christian Mancini, Anna R Wolfson, Rebecca R Saff, Upeka Samarakoon and 12 more

Abstract readMulticenter Study
In one paragraph

Article in The journal of allergy and clinical immunology. In practice, 2023. 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

22 authors.

Cosby A StoneDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Lacey B RobinsonHarvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
Lily LiHarvard Medical School, Boston, Mass; Division of Allergy and Clinical Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
Matthew S KrantzDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Jason H KwahDepartment of Internal Medicine, Section of Rheumatology, Allergy, and Immunology, Yale School of Medicine, New Haven, Conn.
Gilbert OrtegaDivision of Allergy and Immunology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
Christian ManciniDivision of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
Anna R WolfsonHarvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass.
Rebecca R SaffHarvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass.
Upeka SamarakoonDivision of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
David I HongHarvard Medical School, Boston, Mass; Division of Allergy and Clinical Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
Grace KooDivision of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Timothy G ChowDivision of Allergy and Immunology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
Rebecca GruchallaDivision of Allergy and Immunology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
Jane X LiaoDepartment of Internal Medicine, Section of Rheumatology, Allergy, and Immunology, Yale School of Medicine, New Haven, Conn.
John K KusterDepartment of Internal Medicine, Section of Rheumatology, Allergy, and Immunology, Yale School of Medicine, New Haven, Conn.
Christina PriceDepartment of Internal Medicine, Section of Rheumatology, Allergy, and Immunology, Yale School of Medicine, New Haven, Conn.
Catherine AholaDivision of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
David A KhanDivision of Allergy and Immunology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
Elizabeth J PhillipsDivision of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn; Department of Pharmacology, Vanderbilt University School of Medicine, Nashville, Tenn.
Aleena BanerjiHarvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass.
Kimberly G BlumenthalHarvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass; Edward P. Lawrence Center for Quality and Safety, Massachusetts General Hospital, Boston, Mass. Electronic address: kblumenthal@mgh.harvard.edu.

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NATIENS: A Phase III Randomized Double Blinded Study to Determine the Mechanisms and Optimal Management of Stevens-Johnson Syndrome and Toxic Epidermal NecrolysisU01AI154659 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2020 to 2025
$15.5M
Clinical and Translational Training Program in Pulmonary MedicineT32HL087738 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Lorraine B Ware · 2007 to 2026
$7.0M
Genetic risk and long-term outcomes associated with Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in survivorsR01HG010863 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2019 to 2022
$3.1M
Learning Health System Scholar Program at VanderbiltK12HS026395 · AHRQ · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ROTHMAN, RUSSELL L., ROUMIE, CHRISTIANNE L. · 2018 to 2022
$2.7M
Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study)R01AI152183 · NIAID · UNIVERSITY OF CAPE TOWN · PI MEINTJES, GRAEME AYTON, PHILLIPS, ELIZABETH · 2020 to 2025
$1.6M
The Clinical and Economic Impact of Penicillin AllergyK01AI125631 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI BLUMENTHAL, KIMBERLY GOLD · 2016 to 2021
$779k
Stevens-Johnson syndrome/toxic epidermal necrolysis 2021: Collaboration, Innovation and CommunityR13AR078623 · NIAMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2021 to 2021
$33k
AHRQ HHS K12 HS026395NCATS NIH HHS UL1 TR001863NHGRI NIH HHS R01 HG010863NHLBI NIH HHS T32 HL087738NIAID NIH HHS K01 AI125631NIAID NIH HHS R01 AI152183NIAID NIH HHS U01 AI154659NIAID NIH HHS UM1 AI109565NIAMS NIH HHS R13 AR078623
6 · The paper itself

Abstract

backgroundAlthough immediate potentially allergic reactions have been reported after dose 1 of mRNA coronavirus disease 2019 (COVID-19) vaccines, comprehensively defined subtypes have not been clearly distinguished.

objectiveTo define distinct clinical phenotypes of immediate reactions after dose 1 of mRNA COVID-19 vaccination, and to assess the relation of clinical phenotype to mRNA COVID-19 vaccine second dose tolerance.

methodsThis retrospective study included patients with 1 or more potentially allergic symptoms or signs within 4 hours of receiving dose 1 of an mRNA COVID-19 vaccine and assessed by allergy/immunology specialists from 5 U.S. academic medical centers (January-June 2021). We used latent class analysis-an unbiased, machine-learning modeling method-to define novel clinical phenotypes. We assessed demographic, clinical, and reaction characteristics associated with phenotype membership. Using log-binomial regression, we assessed the relation between phenotype membership and second dose tolerance, defined as either no symptoms or mild, self-limited symptoms resolving with antihistamines alone. A sensitivity analysis considered second dose tolerance as objective signs only.

resultsWe identified 265 patients with dose-1 immediate reactions with 3 phenotype clusters: (1) Limited or Predominantly Cutaneous, (2) Sensory, and (3) Systemic. A total of 223 patients (84%) received a second dose and 200 (90%) tolerated their second dose. Sensory cluster (all patients had the symptom of numbness or tingling) was associated with a higher likelihood of second dose intolerance, but this finding did not persist when accounting for objective signs.

conclusionsThree novel clinical phenotypes of immediate-onset reactions after dose 1 of mRNA COVID-19 vaccines were identified using latent class analysis: (1) Limited or Predominantly Cutaneous, (2) Sensory, and (3) Systemic. Whereas these clinical phenotypes may indicate differential mechanistic etiologies or associations with subsequent dose tolerance, most individuals proceeding to their second dose tolerated it.

Indexed as

COVID-19COVID-19 VaccinesHypersensitivity, ImmediateHumansLatent Class AnalysisPhenotypeRetrospective StudiesRNA, MessengerCOVID-19 VaccinesRNA, MessengerAdverse reactionAllergyAnaphylaxisClusterCOVID-19HypersensitivitymRNAPhenotypeSARS-CoV-2Vaccine

Identifiers

PMID36108922
PMCPMC9468049

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