| アブストラクト | OBJECTIVES/BACKGROUND: The main objective of our study was to assess the potential association between coronavirus disease 2019 (COVID-19) vaccination and cluster headache (CH) using a pharmacovigilance approach. A secondary objective was to determine whether COVID-19 vaccines predominantly triggered onset or worsening of the disease. Recent pharmacovigilance studies and case reports have suggested an association between COVID-19 vaccines and cluster headache. In order to evaluate whether COVID-19 vaccines could possibly elicit the onset of cluster headache or be responsible for worsening of the disease, we conducted a retrospective case-non-case pharmacovigilance study using the international VigiBase pharmacovigilance database and analyzed the reported cases of cluster headache in the Base Nationale de Pharmacovigilance, French National Pharmacovigilance Database (BNPV). METHODS: VigiBase was queried up to February 23, 2025, for all reports related to cluster headache and COVID-19 vaccines. To evaluate the potential association, we performed a disproportionality analysis. This analysis relied on the calculation of the information component, for which a 95% confidence interval lower-bound positivity was required for signal detection. The narratives of the reported cases of cluster headache in the BNPV were analyzed to determine whether COVID-19 vaccination was responsible for the onset or worsening of the disease. RESULTS: When focusing on the different COVID-19 vaccines, Vaxzevria was found to be the strongest signal (IC(025): 3.05). Lower signals were observed for the other COVID-19 vaccines, including Comirnaty (IC025: 1.62), Spikevax (IC(025): 1.24), and Jcovden (IC(025): 0.05). The analysis of the 55 CH cases reported in the BNPV revealed a slight predominance of onset (24/55 cases classified as CH) over worsening of the disease (17/55 cases classified as CH). CONCLUSIONS: Our study supports the possibility of a potential association between COVID-19 vaccines and cluster headache through an updated pharmacovigilance analysis. The signal appears to be more pronounced with the Vaxzevria vaccine. |
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| ジャーナル名 | Headache |
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| Pubmed追加日 | 2026/7/6 |
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| 投稿者 | Van Obberghen, Elise K; Parigny, Laura; Ben-Othman, Nouha; Ewig, Elliot; Drici, Milou-Daniel; Gerard, Alexandre O; Gautier, Sophie; Lanteri-Minet, Michel |
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| 組織名 | Pain Department, UR2CA and FHU InovPain, CHU Nice and Universite Cote d'Azur,;Nice, France.;Pharmacology Department, Pharmacovigilance and Addictovigilance Center, French;Addictovigilance Network, CHU de Lille, Lille, France.;Department of Clinical Pharmacology, CHU Nice and Universite Cote d'Azur, Nice,;France.;INSERM U1107 Migraine and Trigeminal Pain, Auvergne University, Clermont-Ferrand, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42403306/ |
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