Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey

  1. Alexander G. Mathioudakis
  2. Murad Ghrew
  3. Andrew Ustianowski
  4. Shazaad Ahmad
  5. Ray Borrow
  6. Lida Pieretta Papavasileiou
  7. Dimitrios Petrakis
  8. Nawar Diar Bakerly

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Abstract

An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05–1.11)), fever (2.24 (1.86–2.70)), breathlessness (2.05 (1.28–3.29)), flu-like illness (1.78 (1.51–2.10)), fatigue (1.34 (1.20–1.49)) and local reactions (1.10 (1.06–1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14–2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01–1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31–0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions.

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  1. Version published to 10.3390/life11030249
  2. ScreenIT

    SciScore for 10.1101/2021.02.26.21252096: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot 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:
    Potential respondents bias is the main limitation of any survey and since this survey was shared though social media, we were not able to estimate the non-response rate. However, respondents bias is more likely to affect the absolute incidence of side effects, that we did not evaluate here, rather than the relative incidence and severity across different groups of people. Potential recall bias should also be mentioned, although all participants had been vaccinated within 10 weeks prior to completing the survey. As noted, most respondents were from the UK and Greece due to the ability of the investigators to establish contacts quickly to publicise this survey. The UK has also been successful in rolling out COVID-19 vaccines quickly leading to more of those invited being eligible to participate. It is not surprising that Pfizer vaccine was the most delivered vaccine as it was the first vaccine to be licensed within the UK, with more individuals receiving it in total when the survey was circulated. In conclusion, this extensive survey of over 2,000 recipients of the COVID-19 vaccines links previous COVID-19 illness with increased incidence of vaccination side effects. It also demonstrates that mRNA vaccines cause milder, less frequent systemic side effects, but more local reactions. These findings will need to be validated in clinical studies, preferably randomized controlled trials, including patients from multiple groups.

    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 10.1101/2021.02.26.21252096v1 on medRxiv