Cerebral Venous Sinus Thrombosis is not Significantly Linked to COVID-19 Vaccines or Non-COVID Vaccines in a Large Multi-State Health System.
J Stroke Cerebrovasc Dis
; 30(10): 105923, 2021 Oct.
Article
in English
| MEDLINE | ID: covidwho-1300924
ABSTRACT
OBJECTIVE:
To assess the association of COVID-19 vaccines and non-COVID-19 vaccines with cerebral venous sinus thrombosis (CVST). MATERIALS ANDMETHOD:
We retrospectively analyzed a cohort of 771,805 vaccination events across 266,094 patients in the Mayo Clinic Health System between 01/01/2017 and 03/15/2021. The primary outcome was a positive diagnosis of CVST, identified either by the presence of a corresponding ICD code or by an NLP algorithm which detected positive diagnosis of CVST within free-text clinical notes. For each vaccine we calculated the relative risk by dividing the incidence of CVST in the 30 days following vaccination to that in the 30 days preceding vaccination.RESULTS:
We identified vaccination events for all FDA-approved COVID-19 vaccines including Pfizer-BioNTech (n = 94,818 doses), Moderna (n = 36,350 doses) and Johnson & Johnson - J&J (n = 1,745 doses). We also identified vaccinations events for 10 common FDA-approved non-COVID-19 vaccines (n = 771,805 doses). There was no statistically significant difference in the incidence rate of CVST in 30-days before and after vaccination for any vaccine in this population. We further found the baseline CVST incidence in the study population between 2017 and 2021 to be 45 to 98 per million patient years.CONCLUSIONS:
This real-world evidence-based study finds that CVST is rare and is not significantly associated with COVID-19 vaccination in our patient cohort. Limitations include the rarity of CVST in our dataset, a relatively small number of J&J COVID-19 vaccination events, and the use of a population drawn from recipients of a SARS-CoV-2 PCR test in a single health system.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Sinus Thrombosis, Intracranial
/
Vaccination
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Cohort study
/
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
J Stroke Cerebrovasc Dis
Journal subject:
Vascular Diseases
/
Brain
Year:
2021
Document Type:
Article
Affiliation country:
J.jstrokecerebrovasdis.2021.105923
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