Adverse events following COVISHIELD (ChAdOx1nCoV-19) vaccination among health care workers in Sri Lanka; a multi-centre cross sectional survey

  1. S.R. Manilgama
  2. N.M. Hettiarachchi
  3. I.K. Jayasinghe
  4. S.T. De Silva
  5. T. Jayalath
  6. T. Wanigaratne
  7. R.P. Bandusiri
  8. N. Suganthan
  9. P. Sudarshan
  10. M. Pathirage
  11. N. Rajaratnam
  12. G. Senaratne
  13. V. Rajapaksha
  14. A. Wickramasinghe
  15. S.P.A.L. Ranaweera
  16. H.M.A. Thilakarathna
  17. M.T.D. Kulaweera

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Abstract

Introduction: A community vaccination programme is the best approach to combat the COVID-19 pandemic. Post-vaccine surveillance is important to identify adverse events (AE) following COVID-19 vaccination in the population.Methods: A multicentre cross-sectional survey was conducted in six provinces to estimate the prevalence of AE following the first dose of COVISHIELD (ChAdOx1nCoV-19) among all categories of health care workers (HCWs). A self-administered questionnaire was used to gather demographic data and AE.Results: Of 5140 participants 67.8% were females. The mean (SD) age was 40.69 (±9.85) years. At least one comorbidity was reported in 15.4%. At least one AE was reported in 86.6% and 49.3% had local AE. Fever (67.2%), headaches (57.3%), body aches (54.4%), chills (51.2%), fatigue (37.5%) and arthralgia (36%) were the most reported systemic AE. The majority of AE lasted less than 24 hours. Pain and redness at the site were the most reported local AE. Mean duration of onset of fever and pain at injection site from the time of the vaccination was 6.65 and 9.67 hours respectively. When participants were divided into two groups by mean age (≤40 and >40 years) and parameters were compared, most systemic (fever, nausea, fatigue, itching) and all local AE were significantly more prevalent in the ≤40 age group. Two percent had reactions within the first 20 minutes. Anaphylaxis developed in 12 participants. Past history of anaphylaxis, drug or food allergy were reported in 0.6%, 2.8% and 6.7% respectively. However, previous history of allergy was not significantly related to immediate reactions or anaphylaxis following vaccination. Despite having minor AE, 71.1% attended routine work while 0.2% required hospitalisation.Conclusions: While 86.6% reported minor AE, only a few serious AE were reported. Overall, the first dose of the vaccine was well-tolerated by HCWs.

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  1. Version published to 10.4038/ajim.v1i1.28
  2. ScreenIT

    SciScore for 10.1101/2022.01.26.22269788: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: After obtaining informed written consent participants were asked to fill the study questionnaire in their preferred language of Sinhala, English, or Tamil.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical Package for Social Sciences (SPSS) software was used for the analysis of data.
    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:
    Strengths and limitations: Recall bias must be considered when documenting onset time and duration of AE. Validated scales are ideal when assessing severity and outcome of AE in large populations. Our study was helpful in identifying the profile of AE following vaccination in a local population in the absence of post-vaccination surveillance in the country. Conclusions and recommendations: Those younger than 40 years reported a higher number of most of the systemic and all local AE. Almost four-fifth of the study population reported minor AE. Serious AE were very few; there were no thrombotic events or neurological complications. The first dose of the vaccine was well-tolerated by the majority of HCWs. Community based vaccine surveillance is mandatory to identify new onset AE following COVID-19 vaccination. The establishment of such a system as part of the routine COVID vaccination programme is strongly recommended.

    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

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  3. Version published to 10.1101/2022.01.26.22269788v1 on medRxiv