Adverse events and their association with comorbidities after first and second doses of Covishield vaccination among healthcare workers of Government owned medical colleges in Kerala

  1. A Remlabeevi
  2. Thomas Mathew
  3. G S Harikumaran Nair
  4. Greeshma Lathika Rajasekharan Nair
  5. Mariyam Rajee Alex

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Abstract

Background

A bridging study in the population was not existing at the time of introduction of Covishield vaccine in the state of Kerala A monitoring network for adverse events which was already in place ensured the reporting of serious adverse events following vaccination, but the recording of symptom profile and timeline of symptoms along with the comorbidity status of the individual recipients needed a further database.

Aims

To find the proportion of vaccine recipients with adverse events following the first and second doses of Covishield vaccination along with assessment of the symptom profile and timeline of appearance of symptoms following vaccination with each dose along with association of adverse events with comorbidity status of the respondents.

Materials & Methods

Cross-sectional study with secondary data taken from the AEFI database of the Covid Cell, Directorate of Medical Education of the Kerala state.The database is formed with responses collected as online self-reporting forms collected from the health workers (doctors, nurses, students, paramedical, housekeeping and clerical staff) who received vaccination from vaccination centres in government owned Medical Colleges in Kerala for a period of three months from the date of rolling out vaccination in the state.

Results

A total of 4402 healthworkers submitted the forms after taking the vaccination,either first dose or second dose.Out of this 3656(83.1%)responders were after first dose and 746(16.9%)participants responded after second dose 63.3% respondents after first dose & 24.3% after second dose reported they had experienced adverse events following vaccination with first or second dose of the vaccine respectively.The first symptom to be noticed in those who reported the adverse event after first dose was body ache (17.9%) followed by headache in 15.1 % of participants. 11% (403 out of 3656)of the responders after first dose were having comorbidities and 8.3 % were taking concomitant medications. History of being an asthmatic was found to be of increased risk for developing symptoms following first dose of vaccination(p value 0.004, OR-1.269,95% CI 1.127-1.429) whereas diabetes mellitus is not identified as a risk factor for development of adverse events though a significant association is found,might be due to a decreased reactogenicity.Among those who responded after receiving second dose of vaccination,24.3% reported they had adverse events(at least one post vaccination symptom),of which the first symptom experienced was headache (25.5%),followed by fever(20.9%) as compared to bodyache and headache after the first dose.

Conclusions

56.7% of those who responded after receiving either first or second dose of the vaccine developed at least one symptom afterwards (63.3% after first and 24.3% after second dose of the vaccine respectively)with mean duration of appearance of symptoms being 8.5 hours and for majority of respondents the symptoms lasted for a day only.The first symptom to appear was bodyache (first dose),fever(in second dose) Though 8.5% respondents had a history of previous Covid infection it had no association with adverse events.Symptoms like chestpain,dry mouth, breathing difficulty which are not being spelled out in Covishield factsheet, has also been reported by the study respondents.Seizures were also reported as an adverse event by the responders

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    SciScore for 10.1101/2021.05.19.21257317: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data was entered into excel 2019 and analysed using SPSS v25.
    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.

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

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  2. Version published to 10.1101/2021.05.19.21257317v1 on medRxiv