Stroke Among SARS-CoV-2 Vaccine Recipients in Mexico

Abstract

Background and objectives:Information on stroke among SARS-CoV-2 vaccines remains scarce. We report stroke incidence as an adverse event following immunization (AEFI) among recipients of 79,399,446 doses of 6 different SARS-CoV-2 vaccines (BNT162b2, ChAdOx1 nCov-19, Gam-COVID-Vac, CoronaVac, Ad5-nCoV, and Ad26.COV2-S) between December 24, 2020, and August 31, 2021, in Mexico.Methods:Retrospective descriptive study analyzing stroke incidence per million doses among hospitalized adult patients (≥18 years) during an 8-month interval. According to the World Health Organization, AEFIs were defined as clinical events occurring within 30 days following immunization and categorized as either non-serious or serious depending on severity, treatment, and hospital admission requirements. Acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and cerebral venous thrombosis (CVT) cases were collected through a passive epidemiological surveillance system in which local health providers report potential AEFI to the Mexican General Board of Epidemiology. Data were captured using standardized case report formats by an ad-hoc committee appointed by the Mexican Ministry of Health to evaluate potential neurologic AEFI against SARS-COV-2.Results:We included 56 patients (female, 31 [55.5%]) for an overall incidence of 0.71 cases per 1,000,000 administered doses (95% confidence interval [CI] 0.54–0.92); median age was 65 years (interquartile range 55–76); median time from vaccination-to-stroke (of any subtype) was 2 days (interquartile range 1–5); in 27 (48.2%) patients, the event was diagnosed within the first 24 hours following immunization. The most frequent subtype was AIS in 43 patients (75%; 0.54/1,000,000 doses, 95% CI 0.40–0.73) followed by ICH in 9 (16.1%; 0.11/1,000,000 doses, 95% CI 0.06–0.22), and SAH and CVT, each with 2 cases (3.6%; 0.03/1,000,000 doses, 95% CI 0.01–0.09). Overall, the most common risk factors were hypertension in 33 (58.9%) patients and diabetes mellitus in 22 (39.3%); median hospital length of stay was 6 days (IQR 4–13); at discharge, functional outcome was good (modified Rankin Scale of 0–2) in 41.1% of patients; in-hospital mortality rate was 21.4%.Discussion:Stroke is an exceedingly rare AEFI against SARS-CoV-2. Pre-existing stroke risk factors were identified in most patients. Further research is needed to evaluate causal associations between SARS-COV-2 vaccines and stroke.

Incidence of Guillain–Barré syndrome following SARS‐CoV‐2 immunization: Analysis of a nationwide registry of recipients of 81 million doses of seven vaccines

“…Aiming to establish causality, an ad hoc committee appointed by the Mexican Ministry of Health, consisting of five experienced neurologists and a neuroradiologist, performed a detailed case‐by‐case analysis of all potentially serious neurological adverse events occurring after SARS‐CoV‐2 vaccination through single or multiple virtual sessions with the individual attending physicians. Operational details of the Mexican epidemiological surveillance system, AEFI definitions, ad hoc committee case evaluation, and data collection protocols have been previously reported [ 19 , 20 ].…”

Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization in Mexico: A nation-wide registry of seven COVID-19 vaccines

“…Operational details of the Mexican epidemiological surveillance system, AEFI definitions, ad-hoc committee case evaluation, and data collection protocols have been previously reported. 18,19…”

Author Response: Stroke Among SARS-CoV-2 Vaccine Recipients in Mexico: A Nationwide Descriptive Study

“…We appreciate the comment on our article. 1 Dr. Stoiloudis reports the case of an otherwise healthy young male individual who developed a wake-up acute ischemic stroke after the second dose of BNT162b2. It is of interest that their patient developed a fever in close temporal association to vaccination, which may be explained by vaccination reactogenicity.…”