Evidence map›Paper›PMID 33946748›Full record

ArticleVaccines2021

Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination.

Abdulla Watad, Gabriele De Marco, Hussein Mahajna, Amit Druyan, Mailam Eltity, Nizar Hijazi, Amir Haddad, Muna Elias, Devy Zisman, Mohammad E Naffaa and 16 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 230 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
230citing papers in PubMed, 12 pooled it
23.0field-weighted citation impact, top 1% 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

230 citing papers in PubMed, 12 syntheses or guidelines pooled it, 369 citations in OpenAlex.

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  20. Perspectives on the Parathyroid-Thymus Interconnection-A Literature Review.International journal of molecular sciences · 2025
    Review

170 more citing papers are in PubMed but not listed here.

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

26 authors at 9 institutions in 4 countries.

Abdulla WatadDepartment of Medicine 'B, Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 10457, Israel.ORCID 0000-0002-1404-8027
Gabriele De MarcoNIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK.
Hussein MahajnaSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Amit DruyanSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Mailam EltityDepartment of Neurology, Sheba Medical Center, Tel-Aviv 10457, Israel.
Nizar HijaziRheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel.
Amir HaddadRheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel.
Muna EliasRheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel.
Devy ZismanRheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel.ORCID 0000-0003-0523-2292
Mohammad E NaffaaDepartment of Rheumatology, Galilee Medical Center, Azrieli Faculty of Medicine, Bar-Ilan University, Safed 22100, Israel.ORCID 0000-0001-9777-2864
Michal BrodavkaSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Yael CohenSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Arsalan Abu-MuchLeviev Heart Center, Sheba Medical Center, Tel Hashomer, Tel Aviv 10457, Israel.
Muhanad Abu ElhijaRheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel.
Charlie BridgewoodNIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK.
Pnina LangevitzSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Joanna McLorinanDepartment of Rheumatology, Mid Yorkshire Hospitals, West Yorkshire WF8 1PL, UK.
Nicola Luigi BragazziCentre for Disease Modelling, Department of Mathematics and Statistics, York University, Toronto, ON M3J 1P3, Canada.ORCID 0000-0001-8409-868X
Helena Marzo-OrtegaNIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK.ORCID 0000-0002-9683-3407
Merav LidarSackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
Cassandra CalabreseCleveland Clinic Foundation, 9500 Euclid Avenue, Desk A50, Cleveland, OH 44195, USA.
Leonard CalabreseCleveland Clinic Foundation, 9500 Euclid Avenue, Desk A50, Cleveland, OH 44195, USA.
Edward VitalNIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK.
Yehuda ShoenfeldDepartment of Medicine 'B, Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 10457, Israel.
Howard AmitalDepartment of Medicine 'B, Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 10457, Israel.ORCID 0000-0002-5406-7716
Dennis McGonagleNIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK.
Tel Aviv University · ILUniversity of Leeds · GBTechnion – Israel Institute of Technology · ILCleveland Clinic · USSheba Medical Center · ILBar-Ilan University · ILCarmel Medical Center · ILMid Yorkshire Hospitals NHS Trust · GBYork University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfectious diseases and vaccines can occasionally cause new-onset or flare of immune-mediated diseases (IMDs). The adjuvanticity of the available SARS-CoV-2 vaccines is based on either TLR-7/8 or TLR-9 agonism, which is distinct from previous vaccines and is a common pathogenic mechanism in IMDs.

methodsWe evaluated IMD flares or new disease onset within 28-days of SARS-CoV-2 vaccination at five large tertiary centres in countries with early vaccination adoption, three in Israel, one in UK, and one in USA. We assessed the pattern of disease expression in terms of autoimmune, autoinflammatory, or mixed disease phenotype and organ system affected. We also evaluated outcomes.

findings27 cases included 17 flares and 10 new onset IMDs. 23/27 received the BNT - 162b2 vaccine, 2/27 the mRNA-1273 and 2/27 the ChAdOx1 vaccines. The mean age was 54.4 ± 19.2 years and 55% of cases were female. Among the 27 cases, 21 (78%) had at least one underlying autoimmune/rheumatic disease prior the vaccination. Among those patients with a flare or activation, four episodes occurred after receiving the second-dose and in one patient they occurred both after the first and the second-dose. In those patients with a new onset disease, two occurred after the second-dose and in one patient occurred both after the first (new onset) and second-dose (flare). For either dose, IMDs occurred on average 4 days later. Of the cases, 20/27 (75%) were mild to moderate in severity. Over 80% of cases had excellent resolution of inflammatory features, mostly with the use of corticosteroid therapy. Other immune-mediated conditions included idiopathic pericarditis (

interpretationDespite the high population exposure in the regions served by these centers, IMDs flares or onset temporally-associated with SARS-CoV-2 vaccination appear rare. Most are moderate in severity and responsive to therapy although some severe flares occurred.

fundingnone.

Indexed as

adenoviral vector-based vaccineCOVID-19immune-mediated diseasesmRNA-based vaccinevaccine safety

Identifiers

PMID33946748
PMCPMC8146571
OpenAlexW3157637563

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.