Thread by @EmpireinWinter

Are adverse events in C19 vaccine trials under-reported?
'A systematic review in PLOS journal analysed 28 studies & found that adverse events were less likely to appear in published journal articles than unpublished studies (e.g. industry-held data).'
maryannedemasi.com/publications/f…

Systematic review in PLOS Journal:
doi:10.1371/journal.pmed.1002127
journals.plos.org/plosmedicine/a…
'strong evidence...much of the information...remains unpublished & that the number & range of adverse events is higher in unpublished than in published versions of the same study.'

'Experts now suggest that the pivotal Covid-19 vaccine trials may have under-reported adverse events in several ways.' [below]

1. Digital apps:
'In the Pfizer & AZ vax trials, participants were given digital apps....But if they experience a serious adverse event like myocarditis or early signs of transverse myelitis, Guillain-Barre Syndrome...or thrombosis, there is no option...to record it on the app.'

2. Dropping subjects w/ serious events, & their data.

'If vax manufacturers selectively withdraw subjects who experience serious adverse events (as in the case of Brianne Dressen & others)...'

This would be consistent with the result that 'trials mostly found “statistically significant” increases in minor adverse events (fever, chills, headaches) but not in serious harms.'

3. Attributing cause to underlying condition:
'When Pfizer recruited 12-15 year olds for its mRNA vaccine trial, the published data in the NEJM, stated that there were “no serious vaccine-related adverse events.”'

'One of the participants in the trial was 13-year-old Maddie De Garay. She was randomly assigned to the vaccine group & following her first injection, [she...] suffered a severe adverse reaction, leaving her in a wheelchair & fed by a nasogastric tube.'

'She was referred to hospital for a full assessment & a doctor diagnosed [her] w/ a “functional disorder”.... this doctor decided that a pre-disposition to “hysteria,” was to blame for her physical disability - not the vaccine...'

'-- & on this basis, she was referred to a mental health facility.'
img1.wsimg.com/isteam/ip/ad46…

'Dr David Healy, a psychiatrist based in Ontario, Canada, subsequently conducted a thorough review...found no such history of pre-existing conditions or mental illness'

'"it appears that, in order to maintain Pfizer’s position, this young woman is not getting the treatment that would be ordinarily indicated for the kind of problems she has."'

'In AstraZeneca’s Phase III trial of its vaccine, the one in which Brianne Dressen was a participant, the study stated;

“Deaths that were adjudicated as not related to Covid-19 were treated as intercurrent events and therefore censored at the date of death.”'

3. Failure to count deaths
'When publishing deaths in the AstraZeneca trial for example, investigators excluded any deaths that occurred immediately after the first dose of the vaccine, up to 14 days after the second dose of the vaccine.'

'In other words: 1) 1st injection, 2) wait for 3 weeks before having 2nd injection, 3) wait a further 2 weeks. That is a total of 5 weeks where deaths were not published.'

'The investigators say it is because participants are not “fully immune” until two weeks after their second dose. That is true.

However, ignoring deaths in that five-week period fails to capture any deaths that might be caused by the vaccine.'

'Dr Healy was very critical of this method of data collection.
“Randomised controlled trials are not supposed to allow decisions like this. All deaths should be reported."'

'"The company can say that they do not think the deaths were caused by the vaccine, but we need a chance to know how many there were and decide if these need further investigation,” said Dr Healy.

'It is important to know what happens in that five week gap because real world data obtained from the CDC (as at 25 June 2021) shows that the majority of reported deaths after a Covid-19 vaccine, occur within 30 days.'

4. The Lesson from 'Controlled Trials':
'So far, reports of serious, life-threatening adverse events linked to the vaccines have not been found in the “gold standard” controlled trials. They were only detected once hundreds of thousands of people had been vaccinated.'

'Myocarditis, for example, only emerged from Israel once they started rolling out the Pfizer vaccine to the population. And reports of vaccine-induced thrombotic thrombocytopenia (VITT) linked w/ the AZ vax first emerged from European surveillance systems, not controlled trials'

'If all Covid-19 vaccine trials are funded, designed, conducted, and analysed by the manufacturers - which is known to distort the results to favour the sponsor’s aims - then more should be done to gain access to the data to allow for independent scrutiny.'

🇨🇦researcher in Israel, Jessica Rose, MSc, PhD, in a presentation to CDC and FDA:

'5,427% increase in deaths following COVID-19 shots, & a 1,373% increase in adverse reactions following COVID-19 shots...'
vaccineimpact.com/2021/phd-resea…

'as compared to all other vaccines given out for the past 10 years.'

Before 2019 VAERS was considered fit for purpose--never intended to establish cause, but to signal further investigation of a trend.

In a previous analysis, Dr. Rose, 'determined that the data in VAERS is under-reported by a factor of X42. This would mean that about one out of every 8 individuals receiving a COVID-19 shot is reporting an adverse reaction.'

For serious events the URF is about 31.

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