Are allergic diseases a risk factor for systemic side effects after COVID-19 vaccines?

  1. Emel Atayik
  2. Gökhan Aytekіn

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Abstract

Background/ aim

Mass vaccination seems to be the most effective way to turn back to the pre-pandemic period and end the pandemic. Unfortunately, COVID-19 vaccines have some side effects. In phase studies of currently-approved COVID-19 vaccines, patients with a known allergy or a history of anaphylaxis were excluded from the studies. This situation creates doubts about the course of atopy and the presence of allergic disease related to the side effects of COVID-19 vaccines in patients with allergic diseases. Therefore, our aim with this study was to evaluate local side effects (LSE) and systemic side effects (SSE) after COVID-19 vaccines in patients with allergic diseases and to determine possible risk factors.

Materials and Methods

Six hundred forty-eight adult patients who received any COVID-19 vaccine between April 1, 2021 and September 30, 2021 and agreed to participate in the study were included in this case-control retrospective study.

Results

Six hundred forty-eight adult patients [Female: 446 (68.8%), Male: 202 (32.2%)] participated in the study. After the 1st dose of COVID-19 vaccine, 24.1% of patients reported SSE. After the 2nd dose of COVID-19 vaccine, 67 patients (12.3%) developed SSE. Female gender (OR: 1.757, 95%Cl: 1.143-2.702, p: 0.010), history of previous COVID-19 infection (OR: 1.762, 95%Cl: 1.068-2.906, p: 0.026), and COVID-19 vaccine type administered (OR: 4.443, 95% CI: 2.640-7.476, p<0.001) were found to be independent risk factors for SSE after COVID-19 vaccines. Premedication (OR: 0.454, 95% Cl: 0.281-0.733, p<0.001), was found to be a protective factor for SSE developing after COVID-19 vaccines.

Conclusion

CoronoVac and Pfizer-BioNTech COVID-19 vaccines are shown to be well tolerated. Patients with allergic disease do not have an increased risk for SSE that may develop after COVID-19 vaccines. Moreover, doubts or fears about possible side effects in the allergic patient group should not be an obstacle to COVID-19 vaccination.

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  1. ScreenIT

    SciScore for 10.1101/2022.01.23.22269704: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Ethics committee approval of the study was granted by Karatay University Ethics Committee (Date: 15.10.2021, decision 2021/012).
    Consent: Written informed consent was obtained from all patients participating in the study.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    IBM SPSS 20.0 (Chicago, IL, USA) statistics software was used for the analysis of all data obtained during the study and recorded in the study form.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    Our study also has some limitations. First of all, the reported LSE and SSE were based on the patient’s statement. Threshold values for side effects may vary among patients. Some patients even consider minor side effects, but some patients may not need to report side effects unless they cause very serious complaints. This situation may have been over-or underestimated. Additionally, the number of patients diagnosed with venom allergy, drug allergy and contact dermatitis is relatively low. This limits the power of statistical analyzes in these patient groups. As a result, in our study, CoronoVac and Pfizer-BioNTech COVID-19 vaccines are shown to be well tolerated. Patients with allergic disease do not have an increased risk for SSE that may develop after COVID-19 vaccines. Clinicians dealing with this patient group should have no doubts in this regard. Moreover, doubts or fears about possible side effects in the allergic patient group should not be an obstacle to COVID-19 vaccination.

    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 10.1101/2022.01.23.22269704v1 on medRxiv