COVID-19 vaccine-associated trigeminal neuralgia: Analysis of the WHO safety database
Fundamental and Clinical Pharmacology
; 36:117-118, 2022.
Artigo
em Inglês
| EMBASE | ID: covidwho-1968126
ABSTRACT
Introduction:
To contain the COVID-19 pandemic, vaccination is deemed as a promising approach. A French pharmacovigilance survey identified five cases of trigeminal neuralgia (TN) following vaccination with AZD1222 (Vaxzevria®, AstraZeneca) [1]. Furthermore, a case report mentioned such an adverse reaction with tozinameran (Comirnaty®, Pfizer-BioNTech) [2]. TN is characterized by recurrent, unilateral, and brief electric shock-like pain in one or more trigeminal divisions [3]. TN is triggered by innocuous stimuli. We aimed to investigate the potential signal of TN related to COVID-19 vaccines. Material andmethods:
We queried VigiBase® (World Health Organization pharmacovigilance database) for all reports of "Trigeminal Neuralgia" (MedDRA Preferred Term) associated with "COVID-19 vaccine" (Active Ingredient), from 1967 to December 29, 2021 [4]. Disproportionality analysis relied on the Reporting Odds Ratio (ROR) with its 95% Confidence Interval (CI), and the Information Component (IC). A positive IC025 is statistically needed to confirm the detection of a signal [5].Results:
In VigiBase®, we gathered 1,283 cases of COVID-19 vaccine-related TN. Most reports involved women (998, 77.8%), with a median age of 52 years, and 510 (39.8%) were deemed serious. Tozinameran was mostly reported with 782 (61.0%) cases, followed by AZD1222 (264, 20.6%), elasomeran (Spikevax® Moderna, 185, 14.4%), and JNJ-78436735 (Janssen® Johnson & Johnson, 37, 2.9%). The association of COVID-19 vaccines and TN revealed significant disproportionality, with an IC025>0 and a ROR of 3.1 (95% CI 2.9-3.3). Tozinameran showed the strongest ROR (3.6;95% CI 3.3-3.8), followed by AZD1222 (2.3;95% CI 2.0-2.6), elasomeran (2.0;95% CI 1.7-2.3), and JNJ-78436735 (1.8 95% CI 1.3-2.5), each with IC025>0. Discussion/Conclusion:
COVID-19 vaccines and TN showed relevant disproportionality. Albeit this reaction may rely on an immune-mediated inflammation, causality can only remain hypothetical in this pharmacovigilance study. Nonetheless, this finding may suggest a signal, strengthening reports mentioned by literature and French pharmacovigilance. A TN occurring after COVID-19 vaccination should alert the clinician.
ad26.cov2.s vaccine; elasomeran; tozinameran; vaxzevria; adult; adverse drug reaction; causality; clinical trial; conference abstract; coronavirus disease 2019; electric shock; female; human; inflammation; major clinical study; Medical Dictionary for Regulatory Activities; middle aged; pharmacovigilance; side effect; trigeminus neuralgia; vaccination; World Health Organization
Texto completo:
Disponível
Coleções:
Bases de dados de organismos internacionais
Base de dados:
EMBASE
Tópicos:
Vacinas
Idioma:
Inglês
Revista:
Fundamental and Clinical Pharmacology
Ano de publicação:
2022
Tipo de documento:
Artigo
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