The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands

ABSTRACT

Background

The effect of a preexisting comorbidity on the occurrence of adverse events after immunization (AEFIs) has been studied poorly. In this longitudinal cohort study, we assess the association between co-morbidities and the occurrence of AEFIs after COVID-19 vaccination. Also, we described the occurrence of flare-ups and their manifestation after COVID-19 vaccination in people with rheumatic diseases.

Research design and methods

We performed multivariable logistic regression to investigate the association between the occurrence of AEFIs and 10 common comorbidities using patient-reported data from people vaccinated with the AstraZeneca, Johnson&Johnson, Moderna, or Pfizer vaccine.

Results

Occurrence of any AEFI, injection site reactions, headache, fatigue, and/or malaise was significantly associated with presence of comorbidities, including psychological disorders, musculoskeletal disorders, and endocrine disorders after the first and second doses (OR ranges 1.23–1.77). One participant with rheumatoid arthritis experienced a flare-up after receiving the first dose of the AstraZeneca vaccine.

Discussion/conclusion

The results showed that the odds of reporting an AEFI after COVID-19 vaccination is significantly higher in the presence of some comorbidities whilst flare-ups are uncommon after receiving COVID-19 vaccination in people with rheumatic disease. In-depth research is needed to validate our results and unravel the observed associations from a mechanistic perspective.

KEYWORDS:

• COVID-19 vaccination
• adverse events
• co-morbidities
• flare-ups
• rheumatoid arthritis

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

The original study protocol was designed by all authors. The dataset was established by TL. Data analysis was performed by CO and JD. The design of the manuscript was determined by all authors. All authors contributed to the final data analysis and to manuscript drafting and revision. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

Ethical approval

If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the central committee on research involving human subjects (CCMO). After submission to an accredited review committee (METC Brabant), this study was deemed not to fall under the WMO act. Participants in the study provided a written statement of consent to participate at the time of registration.

Consent for publication

Participants in the study provided a written statement of consent at the time of registration for their data to be used for the purpose of this research and publication of study results.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2267971

Additional information

Funding

This paper was funded by the Dutch Ministry of Health, Welfare and Sport. The Dutch Ministry of Health, Welfare and Sport had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.