Serious harms of the COVID-19 vaccines: a systematic review

BACKGROUND Serious and severe harms of the COVID-19 vaccines have been downplayed or deliberately excluded by the study sponsors in high impact medical journals. METHODS Systematic review of papers with data on serious adverse events (SAEs) associated with a COVID-19 vaccine. RESULTS We included 18 systematic reviews, 14 randomised trials, and 34 other studies with a control group. Most studies were of poor quality. A systematic review of regulatory data on the two pivotal trials of the mRNA vaccines found significantly more SAEs of special interest with the vaccines compared to placebo, and the excess risk was considerably larger than the benefit, the risk of hospitalisation. The adenovirus vector vaccines increased the risk of venous thrombosis and thrombocytopenia, and the mRNA-based vaccines increased the risk of myocarditis, with a mortality of about 1-2 per 200 cases. We found evidence of serious neurological harms, including Bell’s palsy, Guillain-Barré syndrome, myasthenic disorder and stroke, which are likely due to an autoimmune reaction. Severe harms, i.e. those that prevent daily activities, were underreported in the randomised trials. These harms were very common in studies of booster doses after a full vaccination and in a study of vaccination of previously infected people. CONCLUSIONS Further randomised trials are needed. Authorities have recommended populationwide COVID-19 vaccination and booster doses. They do not consider that the balance between benefits and harms becomes negative in low-risk groups such as children and people who have already recovered from COVID-19 infection. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement Institute for Scientific Freedom and a private funder requesting anonymity, a retired filmmaker with no conflicts of interests in relation to our review. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data are publicly available