"Severe myocarditis weakens the heart so that the rest of the body doesn't get enough blood. Clots can form in the heart, leading to a stroke or heart attack."
https://www.mayoclinic.org/diseases-conditions/myocarditis/symptoms-causes/syc-20352539
FDA saying it's "possible" (page 16):
https://www.fda.gov/media/143557/download
Reports of heart attacks submitted to VAERS sorted by days to onset:
https://openvaers.com/covid-data/cardiac
The key there is "days to onset" which establishes a temporal association. Obviously if 90% of the population has already been vaccinated then anyone who has a heart attack for any reason is roughly 90% likely to have been vaccinated already, so it's unremarkable if they happened to be vaccinated. Similarly, anyone who gets food poisoning is going to be someone who eats food, but the temporal closeness of the poisoning to mealtime is what allows us to associate it with a particular meal.
The burden is to prove
new drugs are safe, not unsafe.
Normally phase 3 trials must be completed before a drug can be deemed safe and marketed -- Pfizer's isn't due to finish until 2024:
https://clinicaltrials.gov/ct2/show/NCT04368728
Actually it will never finish since the placebo group had to be given the treatment for ethical reasons -- letting them get exposed to Covid for research purposes when there is a vaccine available, is considered unethical (and justifiably so imo). Many countries are 90%+ vaccinated now so we might not ever see a large enough placebo group.
"During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died."
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf
(Doesn't prove causation between treatment and mortality, but doesn't bode well for proving safety if the treatment group is expected to have less deaths).
Conflict of interest & had to be
taken to court to release their trial data.
Personally I would be willing to overlook all of this if informed consent was still a thing, and I also believe it's virtuous to volunteer to participate in a clinical trial.
____________________________________________________
Now assuming the burden is to prove the vaccines are UNsafe and caused people to die, I would presume you are already aware of
VAERS mortality reports and hold the position that VAERS data is of insignificant value. But:
"VAERS is the frontline system of a comprehensive vaccine safety monitoring program in the United States. It is one of several systems CDC and FDA use to help ensure vaccines used in the United States are closely monitored for safety."
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vaers.html
“Healthcare providers are required by law to report to VAERS...Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.”
https://vaers.hhs.gov/reportevent.html
“After initial licensure or approval of COVID-19 vaccines in the United States, initial reports may be too few to allow for data mining immediately. As the data mature, PRR and Empirical Bayesian data mining can then be used.”
https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
"Vaccine safety experts review all reports of serious adverse events submitted to VAERS...when VAERS staff members investigate a report of a serious adverse event, they ask for the patient’s medical records related to the serious adverse event to learn more about what happened"
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vaers.html
"VAERS accepts and analyses reports of possible health problems...VAERS scientists review the reports, identify any duplicates, and attach them to the original submission."
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html
“It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators”
https://www.tga.gov.au/media-release/new-web-service-helps-consumer-reporting-side-effects
“In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%).”
https://pubmed.ncbi.nlm.nih.gov/16689555/
“Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines...VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. For anaphylaxis, VAERS captured 13–27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of cases after the 2012–13 inactivated seasonal influenza vaccine, 15–55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine.”
https://www.sciencedirect.com/science/article/pii/S0264410X20312548
Here is a paper which tackles the questions:
1. Is the increase in VAERS reports due to the increase in the number of vaccinations?
2. Is the increase in VAERS reports due to what public health officials refer to as “stimulated reporting,” meaning that people are reporting more due to increased awareness of the existence of VAERS and/or increased fear surrounding the COVID-19 vaccines due to media exposure of adverse events, awareness of the reporting system, mobilization by vaccine critics, etc.
How could we say with confidence that a new product is safe if its users have no reliable way of reporting adverse events? Why do most developed countries have these reporting systems if they are of insignificant value?