NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations.

ABSTRACT

OBJECTIVE: In this Italian population-based study, we aimed to evaluate the neurological complications after the first and/or second dose of COVID-19 vaccines and factors potentially associated with these adverse effects. METHODS: Our study included adults aged 18 years and older who received two vaccine doses in the vaccination hub of Novegro (Milan, Lombardy) between 7 and 16 July 2021. The NEURO-COVAX questionnaire was able to capture the neurological events, onset and duration. That data that were digitized centrally by the Lombardy region were used to match the demographic/clinical characteristics and identify a vulnerability profile. Associations between vaccine lines and the development of complications were assessed. Digital healthcare system matching was also performed to evaluate severe neurological complications (Guillain-Barrè syndrome, Bell's palsy, transverse myelitis, encephalitis) and the incidence of hospital admissions and/or the mortality rate after two doses of the vaccines. RESULTS: The NEURO-COVAX-cohort included 19.108 vaccinated people 15.368 with BNT162b2, 2077 with mRNA-1273, 1651 with ChAdOx1nCov-19, and 12 with Ad26.COV2.S who were subsequently excluded. Approximately 31.2% of our sample developed post-vaccination neurological complications, particularly with ChAdOx1nCov-19. A vulnerable clinical profile emerged, where over 40% of the symptomatic people showed comorbidities in their clinical histories. Defining the neurological risk profile, we found an increased risk for ChAdOx1nCov-19 of tremors (vs. BNT162b2, OR 5.12, 95% CI 3.51-7.48); insomnia (vs. mRNA-1273, OR 1.87, 95% CI 1.02-3.39); muscle spasms (vs. BNT162b2, OR 1.62, 95% CI 1.08-2.46); and headaches (vs. BNT162b2, OR 1.49, 95% CI 0.96-1.57). For mRNA-1273, there were increased risks of parethesia (vs. ChAdOx1nCov-19, OR 2.37, 95% CI 1.48-3.79); vertigo (vs. ChAdOx1nCov-19, OR 1.68, 95% CI 1.20-2.35); diplopia (vs. ChAdOx1nCov-19, OR 1.55, 95% CI 0.67-3.57); and sleepiness (vs. ChAdOx1nCov-19, OR 1.28, 95% CI 0.98-1.67). In the period that ranged from March to August 2021, no one was hospitalized and/or died of severe complications related to COVID-19 vaccinations. DISCUSSION: This study estimates the prevalence and risk for neurological complications potentially associated with COVID-19 vaccines, thus improving the vaccination guidelines and loading in future personalized preventive medicine.