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Covid-19: Two rare vaccine side effects detected in large global study

BMJ 2024; 384 doi: https://doi.org/10.1136/bmj.q488 (Published 26 February 2024)

The largest vaccine safety study to date has identified two new, but very rare, side effects associated with covid-19 vaccines—transverse myelitis and acute disseminated encephalomyelitis.

The Global Vaccine Data Network cohort study included 99 million vaccinated people from 10 sites across eight countries. Researchers compared the observed with expected rate for 13 neurological, blood, and heart related medical conditions.The study, published in Vaccine, confirmed previously identified rare safety signals for myocarditis and pericarditis after a mRNA vaccine (Pfizer and Moderna) and Guillain-Barré syndrome and cerebral venous sinus thrombosis (CVST) after viral vector vaccines (AstraZeneca).

There was a statistically significant increase in Guillain-Barré syndrome within 42 days after the first dose of the AstraZeneca vaccine—76 events were expected and 190 events were observed (observed to expected ratio 2.49; 95% confidence interval 2.15 to 2.87). A statistically significant increased risk of CVST was also observed following the first dose of the AstraZeneca vaccine (OE ratio 3.23; 95% CI 2.51 to 4.09).

The study also confirmed significantly higher risks of myocarditis following the first, second, and third doses of the Pfizer and Moderna vaccines as well as pericarditis after the first and fourth dose of Moderna vaccine, and third dose of AstraZeneca vaccine in the 42 days following vaccination. 

As well as these known risks the researchers also identified a possible safety signal for acute disseminated encephalomyelitis (AEDM) and transverse myelitis with both viral vector and mRNA vaccines.