VAERS data reveals no increased risk of neuroautoimmune adverse events from COVID-19 vaccines

  1. Chris von Csefalvay

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Neuroautoimmune disorders, such as multiple sclerosis and Guillain-Barre syndrome, have been documented in relation to various vaccines in the past. This paper uses passive reporting information from the CDC/FDA’s VAERS system to analyse whether neuroautoimmune presentations are reported at a relatively higher or lower rate, vis-a-vis other adverse effects, for COVID-19 vaccines than for other vaccines. Through computing the reporting odds ratios for a range of symptoms and comparator vaccines, a clear indication in favour of the safety of COVID-19 vaccines emerges, with reports of neuroautoimmune adverse events in relation to other adverse events being over 70% less likely for COVID-19 than for comparator vaccines ( ROR : 0.292, p < 0.0001). In comparison with other vaccines given as part of routine care in adulthood, COVID-19 vaccines have the lowest reporting odds ratio of neuroautoimmune adverse effects (median ROR : 0.246).

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2021.06.13.21258851: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variableExcept for male recipients of the COVID-19 vaccine, age distribution of neuroautoimmune disorders followed a bimodal pattern, peaking in the third and eight decades of life.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Categorisation of cases: Following ingestion using Python v.
    Python
    suggested: (IPython, RRID:SCR_001658)

    Results from OddPub: Thank you for sharing your code and data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Despite the limitations of this study, which drew on passive reporting data with all its inherent problems, such as reporting bias and the lack of a reliable denominator, we have found evidence that supports the safety of COVID-19 vaccines with regard to neuroimmunological presentations. Statistical analysis indicated that in comparison to recipients of other vaccines, those who reported in respect of a COVID-19 vaccines were over 70% less likely to report a neuroimmunological presentation than a non-neuroimmunological presentation. Similarly, the number of reports fell significantly under what was expected in all but two somemwhat cohesive symptom groups: relapses of MS on one hand and autoimmmune encephalitis on the other. The fact that some forms of autoimmune encephalitis are distributed bimodally by age with a peak in the third and the seventh decade of life may support a hypothesis that the increase in cases of autoimmune encephalitis is the consequence of statistical noise and/or sampling bias due to the higher average age of COVID-19 vaccine recipients in the sample.[19] Similarly, multiple sclerosis exhibits a similar bimodality of age distribution, to the point that respective terms for early-onset (teens to early 30s) and late onset (50s and later) MS have become established in the literature.[20] Nevertheless, clinicians may, as a matter of abundance of caution, keep a closer eye on patients with known MS or risk factors for MS (such as previous diagnosis of optic...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.06.13.21258851v2 on medRxiv
  3. Version published to 10.1101/2021.06.13.21258851v1 on medRxiv