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Safety of the first dose of mRNA SARS-CoV-2 vaccines in patients with rheumatic and musculoskeletal diseases
  1. Caoilfhionn M Connolly1,
  2. Jake A Ruddy2,
  3. Brian J Boyarsky2,
  4. Robin K Avery3,
  5. William A Werbel3,
  6. Dorry L Segev2,4,
  7. Jacqueline Garonzik-Wang2,
  8. Julie J Paik1
  1. 1 Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2 Surgery, Johns Hopkins, Baltimore, Maryland, USA
  3. 3 Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA
  4. 4 Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  1. Correspondence to Dr Caoilfhionn M Connolly, Rheumatology, Johns Hopkins University, Baltimore, Maryland 21224, USA; connolly{at}

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The safety of the SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMD) on immunomodulatory therapy is unknown because these individuals were largely excluded from the vaccine trials. The levels of systemic reactogenicity reported with SARS-CoV-2 mRNA vaccines to date have raised concern for a more serious adverse event profile in patients with underlying immune dysregulation. There is currently no direct evidence about mRNA vaccine safety in patients with RMD and current guidance is based on expert opinion.1 Concerns relating to the side effect profile of the SARS-CoV-2 mRNA vaccines have been identified as a primary concern of patients resulting in vaccine hesitancy.2 To assess tolerability and peri-vaccination reactogenicity in this patient population, we studied a sample of patients with RMD on immunomodulatory therapy who underwent early vaccination. 

Patients with RMD who received the SARS-COV-2 mRNA vaccine between 17 December 2020 and 11 February 2021 were recruited to participate in this observational cohort study by invitation on social media. Information on demographics, diagnoses and therapeutic regimens was collected. Participants completed an online questionnaire detailing any reactions experienced within the first week following the first vaccine dose.

We studied 325 participants with RMD, of whom 51% received Pfizer/BioNTech and 49% received Moderna …

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  • Handling editor Josef S Smolen

  • Twitter @CaoilfhionnMD

  • CMC and JAR contributed equally.

  • Correction notice This article has been corrected since it published Online First. Formatting issues within the content have been fixed.

  • Contributors All authors contributed to the creation of this letter in all aspects including data gathering, analysis, writing, and critical revision of the manuscript.

  • Funding This research was made possible with generous support of the Ben-Dov family. This work was supported by grant number F32DK124941 (Boyarsky) and K23DK115908 (Garonzik‐Wang) from the National Institute of Diabetes and Digestive and Kidney Diseases, K24AI144954 (Segev) from National Institute of Allergy and Infectious Diseases, K23AR073927 (Paik) from National Institute of Arthritis and Musculoskeletal and Skin Diseases and by a grant from the Transplantation and Immunology Research Network of the American Society of Transplantation (Werbel). The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organisations imply endorsement by the US Government.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.