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

Vaccine Elsevier

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.

Authors with CRIS profile

Ryan Crisp Lehrstuhl für Chemistry of thin film materials

Involved external institutions

REGIOMED Klinikum Lichtenfels DE Germany (DE) Otto-Friedrich-Universität Bamberg DE Germany (DE)

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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