Impact of the medical briefing and vaccine type on adverse events following COVID-19 vaccination: A randomized clinical trial

Beller NS, Beller M, Murmann JJ, Crisp R (2025)


Publication Type: Journal article

Publication year: 2025

Journal

Book Volume: 61

Article Number: 127392

DOI: 10.1016/j.vaccine.2025.127392

Abstract

Adverse events (AE) of varying severity commonly occur after vaccinations, potentially related to the nocebo effect. The randomized single-center clinical trial “LIFe Study” at the Vaccination Center Lichtenfels, Germany, investigates AE based on doctor-patient interaction and administered vaccine type following COVID-19 vaccination. Vaccinees receiving first or second doses were randomized: the control group (n=1,006) received in-depth medical briefings elaborating all possible AE; the experimental group (n=937) concise medical briefings comprising only medically relevant facts to the. Nocebo effects were quantified by self-reported AE frequency and severity; then AE across vaccine types and vaccinee demographics were compared including vaccinees receiving third (booster) doses. Questionnaires allowed rating 12 listed AE from absent, mild, moderate, to severe (valued as {0,1,2,3}, respectively), and summed to yield a score ranging from 0 to 36. Most AE were mild with no significant difference in mean AE (mAE) score between control (3.95, σ = 4.70) and experimental groups (3.96, σ = 4.75), nor in the number of participants reporting drug use for symptom relief (ncontrol = 208, nexperimental = 192; p = 0.54), or sick leave (ncontrol = 82, nexperimental = 82; p = 0.32). Higher mAE were associated with follow-up doses of Spikevax compared to Comirnaty, young age (r = -0.15, 95% CI [-0.19; -0.11], p = 9×10-12), and female gender (mAE 5.00, σ = 5.32 vs male 3.05, σ = 3.93). These findings suggest that the nocebo effect was not a significant factor in COVID-19 vaccinations and allow optimization of future vaccination strategies.

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How to cite

APA:

Beller, N.S., Beller, M., Murmann, J.J., & Crisp, R. (2025). Impact of the medical briefing and vaccine type on adverse events following COVID-19 vaccination: A randomized clinical trial. Vaccine, 61. https://doi.org/10.1016/j.vaccine.2025.127392

MLA:

Beller, Nora S., et al. "Impact of the medical briefing and vaccine type on adverse events following COVID-19 vaccination: A randomized clinical trial." Vaccine 61 (2025).

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