Related Experiment Video
Updated: Sep 1, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
Published on: May 11, 2020
Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional
Charles Khouri1,2, Ayoub Larabi3, Pierre Verger4,5,6
1Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France. CKhouri@chu-grenoble.fr.
Introduction:
Little is known about the impact of mandatory vaccination on people who are reluctant to be vaccinated, despite the potential importance in terms of public health policy.
Objective:
We aimed to explore the relationship between vaccine hesitancy and onset, severity and characteristics of self-reported adverse events.
Methods:
We used a cross-sectional online survey conducted in 2021 among a representative sample of the French population aged 18 years and older (n = 1593). All reported adverse events were analyzed and categorized by trained experts in drug safety and pharmacovigilance. Multivariate binomial regressions on the onset of self-reported adverse events, vaccine hesitancy categories and predefined responders' characteristics were performed.
Results:
Overall, 590 (37.0%) participants reported at least one adverse event, with 121 (20.5%) considered it to be severe. Proportions of reported adverse events, ranging from 18% (in non-reluctant responders) to 65% (in very reluctant responders), and their severity, ranging from 5% (non-reluctant responders) to 41% (very reluctant responders), depended highly on attitudes toward vaccination. The adverse events profile remained similar between groups. In the multivariate regression model, beyond attitude toward vaccination, younger age and female gender were significantly associated with higher reporting of vaccine adverse events.
Conclusions:
Our results suggest that vaccine hesitancy could be a major driver of patient-reported vaccine-related adverse events and their perceived severity. In this context, vaccinators must pay special attention to reluctant patients and inform them on the possible nocebo nature of these adverse events so as to prevent them.
Related Concept Videos
Vaccinations
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Bias in Epidemiological Studies
Prevalence and Incidence
Prevalence indicates the proportion of individuals in a population who have a specific disease or health...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Factors Affecting the Risk of Infection
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...

