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Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting
Kimberly N Garces1, Alexandra N Cocores1, Peter J Goadsby2,3
1Division of Headache, Department of Neurology, University of Miami, Miller School of Medicine, Miami, FL, USA.
Current Pain and Headache Reports
|November 23, 2022
Summary
Headache is a common vaccine adverse event (VAE) across various clinical trials. Further research is needed to standardize headache assessment and management following vaccination.
Area of Science:
- Vaccinology
- Clinical Trials
- Pharmacovigilance
Background:
- Headache is a frequently reported symptom in vaccine recipients.
- Understanding headache as a vaccine adverse event (VAE) is crucial for vaccine safety monitoring.
Purpose of the Study:
- To characterize the incidence and patterns of headache as a VAE in clinical trials.
- To review the prevalence of headache across different vaccine types.
Main Methods:
- Systematic review of recent phase III vaccine randomized controlled trials (RCTs) non-COVID-19.
- Analysis of headache reporting in infectious agent vaccine trials and COVID-19 vaccination trials.
Main Results:
- Headache was reported in 53% of non-COVID-19 vaccine RCTs, with a median rate of 15.6%.
- Headache occurred more frequently in vaccine groups compared to placebo in 24.5% of trials.
- Herpes zoster, influenza, and HPV vaccines showed notable rates of headache as a VAE.
- Median post-vaccination headache rate for COVID-19 vaccines was 39%.
Conclusions:
- Headache is a common VAE in vaccine trials.
- Standardized methods for grading headache, identifying predictors of persistence, and establishing treatment guidelines are necessary.
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