3 ms·
> Post-EUA safety surveillance reports received by FDA and CDC identified increased risks of myocarditis and pericarditis, particularly within 7 days following
by OrvalWintermute 5y ago
> Post-EUA safety surveillance reports received by FDA and CDC identified increased risks of
myocarditis and pericarditis, particularly within 7 days following administration of the second
dose of the 2-dose primary series. Reporting rates for medical chart-confirmed myocarditis and
pericarditis in VAERS have been higher among males under 40 years of age than among
females and older males and have been highest in males 12 through 17 years of age (~71.5
cases per million second primary series doses among males age 16-17 years and 42.6 cases
per million second primary series doses among males age 12-15 years as per CDC
presentation to the ACIP on August 30, 2021). * In an FDA analysis of the Optum healthcare
claims database, the estimated excess risk of myocarditis/pericarditis approached 200 cases
per million fully vaccinated males 16-17 years of age and 180 cases per million fully vaccinated
males 12-15 years of age * .44 Although some cases of vaccine-associated myocarditis/pericarditis
have required intensive care support, available data from short-term follow-up suggest that most
individuals have had resolution of symptoms with conservative management. Information is not
yet available about potential long-term sequelae and outcomes in affected individuals, or
whether the vaccine might be associated initially with subclinical myocarditis (and if so, what are
the long-term sequelae). A mechanism of action by which the vaccine could cause myocarditis
and pericarditis has not been established. Myocarditis and pericarditis were added as important
identified risks in the PVP and included in the Warnings sections of the vaccine Fact Sheets and
Prescribing Information. The Sponsor is conducting additional post-authorization/post-marketing
studies to assess known serious risks of myocarditis and pericarditis as well as to identify an
unexpected serious risk of subclinical myocarditis.
I pulled out the text from your link which is the applicable text with most apropos italicized
Given what we know thus far I think it is consistent with the research to say that this is likewise, potentially caused by intravenous injection of the vaccine, rather than intramuscular as properly indicated. This is also partially caused by modern vaccine procedures which rarely involve aspiration, therefore, the medical provider has no clear indication of whether or not they are injecting into muscle or veins.
As someone that considers himself vaccine-hesistant, I consider this to be a big potential victory in addressing arguably one of the most concerning side effects with mRNA based vaccines, and reducing my concern level if I am required to get the vaccine.