How Safe is Covishield (ChAdOx1nCoV-19) Vaccine? Experience from a Tertiary Care Hospital in South India

  1. Leeberk Raja Inbaraj
  2. Carolin Elizabeth George
  3. Nirupama Navamani Franklyn

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Abstract

Coronavirus disease vaccine has been recently rolled out for health care workers in India. We aimed to determine the incidence of adverse events following immunization (AEFI) among healthcare workers (HCWs) after their first dose of the ChAdOx1nCoV-19 vaccine.

Methodology:

We recruited 218 HCWs for this cross-sectional study. We circulated a google form on the hospital and asked them to self-report their vaccination experience.

Results:

Two-thirds (69.7%, 95% confidence interval [CI]: 63.1–75.7) had minor AEFI, and none had severe AEFI. Body ache (46.8%, 95% CI: 40–53.6) was the most common symptom followed by headache (30.3%, 95% CI: 24.2–36.8). Most of them (39.4%, 95% CI: 32.9–46.2) experienced symptoms within 4–24 h after taking the vaccine. Majority (78.9%) were anxious before the vaccination. The younger age group and female gender were significantly associated with AEFI.

Conclusion:

HCWs experienced minor, self-limiting AEFI with the first dose of ChAdOx1nCoV-19. The hospital reported no serious AEFI following the vaccination.

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  1. Version published to 10.4103/cmi.cmi_50_21
  2. ScreenIT

    SciScore for 10.1101/2021.03.16.21253744: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: We circulated a google form with informed consent on the hospital WhatsApp platform and asked them to self-report their vaccination experience.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data were analyzed in Statistical Package for the Social Sciences (SPSS) version 20.0.
    Statistical Package for the Social Sciences
    suggested: (SPSS, RRID:SCR_002865)
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    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.

  3. Version published to 10.1101/2021.03.16.21253744v1 on medRxiv