VAERS data reveals no increased risk of neuroautoimmune adverse events from COVID-19 vaccines

Abstract

Neuroautoimmune disorders, such as multiple sclerosis and Guillain-Barre syndrome, have been documented in relation to various vaccines in the past. This paper uses passive reporting information from the CDC/FDA's VAERS system to analyse whether neuroautoimmune presentations are reported at a relatively higher or lower rate, vis-a-vis other adverse effects, for COVID-19 vaccines than for other vaccines. Through computing the reporting odds ratios for a range of symptoms and comparator vaccines, a clear indication in favour of the safety of COVID-19 vaccines emerges, with reports of neuroautoimmune adverse events in relation to other adverse events being over 70% less likely for COVID-19 than for comparator vaccines (ROR: 0.292, p < 0.0001). In comparison with other vaccines given as part of routine care in adulthood, COVID-19 vaccines have the lowest reporting odds ratio of neuroautoimmune adverse effects (median ROR: 0.246).

Vitamin B12 and D deficiency as cofactors of COVID-19 vaccine-induced chronic neurological adverse reactions: Two cases and a hypothesis

“…Previous research has suggested a range of neuro-immune mediated COVID-19 vaccine responses, although the link to neuro-autoimmunity is not clear (Csefalvay, 2021). To our knowledge, the role of vitamin B12 deficiency has not been properly investigated as part of these responses.…”

A systematic review of cases of CNS demyelination following COVID-19 vaccination

“…As of September 2021, VAERS database had 328 reports of suspected cases of TM worldwide, following all types of vaccines ( von Csefalvay, 2021 ). However, a recent analysis of VAERS data revealed no increased risk of neuroautoimmune adverse events from COVID-19 vaccines compared to other vaccines ( Beh et al, 2013 ).…”

A case-control study of autoimmune AEFIs following COVID-19 vaccination reported to VAERS

“…This confirms previous findings as to the safety of COVID-19 vaccines with respect to neuroautoimmune AEFIs. [12] Only three specific autoimmune aetiologies exceed the reporting odds ratio of 2.0, which is widely considered the minimum for signal generation in passive pharmacovigilance. Psoriasis (ROR = 2.99, p < 0.001, 95% CI: 2.34-3.82) and myasthenia gravis (ROR = 3.90, p < 0.001, 95% CI: 2.63-5.80) were observed with a somewhat elevated ROR vis-a-vis other vaccines and other potential AEFIs.…”

“…This study confirms previous findings as to the safety of the COVID-19 vaccine with regard to neuroautoimmune disorders. [12] In particular, with respect to Guillain-Barre syndrome, patients were three times as likely to have received a non-COVID-19 vaccine than a COVID-19 vaccine. The absence of a neuroautoimmune safety signal may be usefully emphasised in reassuring the population about the COVID-19 vaccines, especially considering the prominent position such side effects occupy in the landscape of concerns about vaccines that drive vaccine hesitancy.…”

“…Nor is there an established system to deduplicate reports that may have been submitted by multiple parties to the same event, potentially without each other's knowledge. [12] This results in a significant potential for overreporting of AEFIs to VAERS.…”