Incidence and Risk Factors of Immediate Hypersensitivity Reactions and Immunization Stress-Related Responses With COVID-19 mRNA Vaccine

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Abstract

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  1. SciScore for 10.1101/2022.01.12.22269134: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This study was reviewed and approved by the Institutional Review Board of the Self-Defence Forces Central Hospital, Tokyo, Japan (Approval number: 03-006).
    Consent: Informed consent was obtained from all participants in the form of opt-out.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.


    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    There are several limitations to this study. First, a selection bias may limit the generalisability of our findings. This study was conducted at a single centre and a single country. ISRR can be affected by environmental factors of the vaccination centre and can occur in clusters or group settings.26 Therefore, the incidence rate of ISRR cannot be specified in a mass vaccination centre. Second, the possibility of underestimation of the incidence rate of IHSR and ISRR cannot be denied. The observation period after the administration of the vaccine was limited (mean observation time was 20 minutes: Supplementary method 1) due to the study design. Third, the sample size of the case with IHSR was smaller than planned due to the low incidence rate of IHSR in our study (Supplementary method 2). Therefore, our sample size of IHSR may not have statistical power to detect the factors that slightly increased the risk of IHSR with a low prevalence rate, such as atopic dermatitis, in the sensitivity analysis. We suggest that multicentre and multinational studies may complement the limitations of our study.

    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.