Side effects

Concerns of Fraud in Pfizer Vaccine Trial as Participant’s Hospitalisation with Heart Inflammation is Swept Under Carpet

You may have heard the disturbing story of Maddie de Garay, who in July 2020, aged 12, participated in Pfizer’s Covid vaccine trial of adolescents aged 12-15. Within 24 hours of receiving the second dose in early January 2021, Maddie experienced “zapping pain up and down her spine with severe abdominal pain… her toes and fingers turned white and were ice cold”. She now can barely see, suffers from tinnitus, mobility issues, vomiting, blood in her urine, numbness in her body and has at least 10-20 seizures a day. Yet her injury was recorded in the vaccine trial data as “abdominal pain” and it was asserted without investigation to be not related to the vaccine.

Another case, similarly disturbing, has now emerged of an adverse reaction during a Pfizer trial that was not recorded in the trial data, raising concerns about the integrity of the trial data and the possibility of fraud.

Augusto Roux is a 35-year old lawyer from Buenos Aires, Argentina who volunteered for Pfizer’s Covid vaccine phase 3 trial. He did so to protect his mother, who has emphysema.

On the way home after his second dose on September 9th 2020, he began feeling unwell, developed a high fever and felt very ill. He fainted on September 11th and went to the hospital on September 12th. The hospital ran tests, including a CAT scan of his chest, which showed an abnormal collection of fluid around the outside of the heart, indicating pericarditis (a form of heart inflammation).

mRNA Vaccines Significantly Associated With Deadly Blood Clots, Major Study Finds

Blood-clotting condition cerebral venous thrombosis (CVT), which can cause serious neurological damage, is significantly associated with mRNA Covid vaccination, a major study in leading medical journal Vaccines has found.

The research team analysed 1,154,023 adverse event reports from more than 130 countries logged with VigiBase, the World Health Organisation’s global deduplicated database, and found a “potential safety signal for CVT occurrence after COVID-19 mRNA vaccination”.

The authors note many reports were in younger people and the conditions were serious: “CVTs were commonly reported in patients aged 18-44 and 45-64 years, more frequently in women, and mainly in Europe and America… More than 90% of the patients were in serious condition, and 33% did not recover or died.”

The researchers take into account under-reporting to produce estimates of increased risk above a baseline: around 3.5 times greater risk for mRNA vaccines and seven times greater risk for AstraZeneca. This means the CVT risk from mRNA vaccines, while high, is around half that of AstraZeneca.

U.K. Covid Inquiry Proposes to Examine Vaccine Deaths

The Chair of the U.K. independent public Covid inquiry, Baroness Heather Hallett, has told the Prime Minister she wants her inquiry to cover vaccine side-effects and fatalities. The Mail has the story.

Very rare yet serious side-effects from the Covid vaccine could be explored in the forthcoming public inquiry into the pandemic.

It may also look into the struggle which affected families have faced in getting compensation.

Probe chairwoman Baroness Heather Hallett wrote to the Prime Minister last Thursday outlining the key areas under scrutiny – including pandemic preparedness, lockdowns, testing, PPE and care homes – which he will have to sign off before the inquiry can begin.

The Mail on Sunday has learned that she also asked if her inquiry can cover deaths and life-changing side-effects from the jabs.

While multiple studies have shown Covid vaccines to be safe – with more than 53 million Britons having had at least one dose and nearly 40 million receiving three – a small minority of people suffered serious health problems including blood clots and inflammation in the heart.

In the U.K., medical regulators have reported 438 blood clot cases and 79 deaths linked to the AstraZeneca vaccine. 

More than 900 applications have now been filed for compensation over death or injury due to vaccines, with the total claims reaching £110 million. However, not a single payment has been made.

The inquiry seems unlikely to explore this issue properly if only because the data collected and published on it to date are so limited and poor. But it is reassuring at least that the head of the inquiry wants to cover it, and presumably the Prime Minister will not refuse permission. Good also to see pandemic preparedness in there – it will be interesting to see what the inquiry makes of the Government’s performance when assessed against its own plans.

Worth reading in full.

MP Calls on the Government to Properly Compensate the Vaccine Injured

Conservative MP Sir Christopher Chope has taken on the unenviable mantle of championing the cause of the vaccine injured in Parliament and to a Government that seems to want to pretend the problem isn’t there. He has a piece in ConservativeHome today saying things are finally moving, but the situation is still far from adequate.

The Government accepted that COVID-19 vaccines might cause serious harm to some people when it decided to bring COVID-19 vaccine damage within the ambit of the existing Vaccine Damage Payment Scheme (the “VDPS”).

But ever since, it has been stalling on addressing those who have claimed. Not a single one of over 1,300 claims has yet been decided, not even those in which a coroner’s verdict has determined that the vaccine was the cause of death. It is intolerable that the Government is failing those people who did the right thing, were vaccinated, but then suffered serious harm or bereavement as a result.

I first raised the issue in Parliament last June, when I presented a Private Members’ Bill. This was briefly debated in September, when I called for an independent review of disablement caused by COVID-19 vaccines and better compensation arrangements for those who have suffered. Since then, I have received hundreds of emails, often with harrowing reports from the families and friends of those who tragically died or continue to suffer severe injury or life-changing consequences.

After a barren year, there is now some positive news to report. The Minister for Vaccines and Public Health, Maggie Throup, has confirmed that external assessors will begin assessing claims next week, on May 16th. They are contracted to assess 1,800 claims in the first year. It is worth comparing the scale of this with the situation pre-Covid, when only 80 vaccine claims were being made each year…

The assumption must be that the policy of non-engagement on this issue was deliberate. Public health officials are keen to avoid scrutiny about the fact that the vaccines are not 100% safe. The Medicines & Healthcare products Regulatory Agency has received more than 450,000 suspected adverse reaction reports under its Yellow Card scheme, with the first report dating back to December 9th 2020.

The truth about the vaccines not being absolutely safe is therefore out in the open. My argument to the Government is that being in denial about vaccine damage is undermining the very vaccine confidence which the Government has been trying to promote. The consequence of this is apparent from the declining take up of boosters.

At my meeting with the Minister, I asked her whether the Government agreed that some people had died as a direct result of having received COVID-19 vaccines. Much to my surprise, she could not answer that question, and requested more time in which to do so in writing. She promised such a response within 14 days, but told me this week that she will respond to me “shortly”.

This shows that the Government is really agonising over whether or not to admit that, for some, COVID-19 vaccines have had fatal consequences. This is all the more bizarre when the Yellow Card scheme refers to over 2,000 fatalities, the Office for National Statistics has confirmed a series of fatalities, and even the AstraZeneca COVID-19 vaccine product information leaflet confirms fatal outcomes were observed.

I wonder, is the piece on ConHome instead of in a national newspaper by choice or because the newspapers wouldn’t run it?

Worth reading in full.

Vaccinated Hospitalised for Non-Covid Reasons at FIVE Times the Rate of the Unvaccinated, U.K. Government Data Show

Over the past 15 months we’ve had a barrage of statistics presented to us shouting about how great the vaccines are at preventing hospitalisation from (or with) Covid. However, these statistics have been light on detail on how they were calculated and we’ve not seen much sight at all of the raw data that the statistics were based upon.

Until now. In April, a paper was published by the UKHSA (currently in pre-print, which means that it hasn’t yet undergone the usual peer-review process) on its statistical analysis of a selection of hospitalisation data by vaccination status. The intent of this paper was to support its statements that the vaccines prevent hospitalisation. However, the paper also includes the raw data upon which the UKHSA statistics were derived, and these data tell a very different story to that presented by the UKHSA. The data show:

  • Far higher accident and emergency admission rates for reasons other than Covid in the vaccinated than in the unvaccinated.
  • Much higher rates of hospitalisation due to non-Covid acute respiratory illness in the vaccinated.
  • Even higher A&E admissions and hospitalisations in the double-vaccinated (not boosted).
  • Even where the data suggest that the vaccines offer some protection (the risk of admission to intensive care resulting from Covid infection) the results look like they might be an artefact created by the assumptions used by the UKHSA.

Vaccine Safety Update

This is the 31st of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 30th one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This was done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr. Tess Lawrie in June wrote an open letter to Dr. June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • The U.S. FDA has limited access to Johnson & Johnson’s COVID-19 vaccine because of the risk of blood clots, making it available now only to over-18s who cannot take one of the mRNA vaccines for medical reasons or are not willing to take one.
  • A family GP practice in the USA has said it is not able to sign off vaccinated student athletes for sport without lab work to check their heart.
  • Data released by the U.K. Government show the all-cause mortality rate is substantially higher in those who have received one or two doses of the Covid vaccine than in the unvaccinated.
  • The U.K. Government has launched an urgent investigation into an increase in severe hepatitis amongst children. Hepatitis is a known vaccine side-effect, though any potential link of this outbreak with the vaccines would be indirect as almost all the children affected are unvaccinated (most are too young).
  • A study has shown that Covid vaccination can elicit a distinctive form of hepatitis (liver inflammation) which is “CD8 T-cell dominant”.
  • Case report on severe and fatal rhabdomyolysis (muscle tissue damage) after Covid vaccination.
  • A piece in Spectator Australia asks questions about adverse events in the country linked to the Covid vaccines.
  • Pfizer has submitted an application to the FDA for U.S. Emergency Use Authorisation for a COVID-19 vaccine booster dose in children aged five to 11.
  • A study has found significant menstrual issues related to Covid jabs including a massive increase in the previously rare event of “decidual cast shedding”.
  • Geert Vanden Bossche says he has informed the WHO of the dangers associated with continuing the Covid vaccine campaign.
  • Adverse events reported in the U.K. press: Mollie Brown, 21; Oli Akram Hoque, 26; Peter Jackson, 96; Dawn Wooldridge, 36.
  • Eudravigilance – the European version of the Yellow Card Reporting system – as of April 30th has reported 4,241,317 reactions from 1,755,775 reports of which 1,933,161 were deemed as serious. 44,161 fatal reactions were reported with an approximate actual number of deaths being 14,379. This is due to a 3.07 reporting rate in fatalities across multiple reactions.
  • VAERS – the American version of the Yellow Card reporting system – as of April 29th reports a total of 1,247,131 reports of adverse events following Covid vaccines, including 27,532 deaths and 226,340 serious injuries. For children up to the age of 17 there have been 48,033 reports, of which 4,296 were deemed serious and 106 fatalities. 
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to April 20th) 124,087 reports of adverse events, including 828 deaths.
  • Children (Under 18) Adverse Events U.K. – up to April 20th, the MHRA reports a total of 3,873 adverse event reports, comprising 3,558 Pfizer, 263 AstraZeneca, 26 Moderna and 26 unspecified from 3,613,500 children vaccinated with 5,926,600 doses. This includes 76 reported cases with Pfizer of myocarditis/pericarditis, suggesting a current reported risk of 14 cases per million first doses and 11 per million second doses for this age group.
  • Booster Doses – 48,612 adverse events have been reported across all vaccines up to March 30th from 39,108,473 people vaccinated.

Summary of Adverse Events in the U.K.

According to an updated report, as of April 20th the MHRA Yellow Card reporting system has recorded a total of 1,485,059 events based on 453,680 reports. The total number of fatalities reported is 2,096.

Serious Adverse Effects of Covid Vaccines 40 Times Higher Than Recorded by Government, German Scientist Says

The number of serious adverse effects from Covid vaccination is 40 times higher than currently recorded by the German Government, a scientist leading a study into the vaccines has said. German news outlet MDR has the story (translated via Google).

The study “Safety Profile of COVID-19 Vaccines” (“ImpfSurv” for short), which focuses on the effects and side effects of the various vaccines, has been running for a year. Around 40,000 vaccinated people are interviewed at regular intervals throughout Germany. Participation in the study is voluntary and independent of how the vaccines work in the subjects.

One result: eight out of 1,000 vaccinated people struggle with serious side effects. “The number is not surprising,” explains Prof. Dr. Harald Matthes, head of the study: “It corresponds to what is known from other countries such as Sweden, Israel or Canada. Incidentally, even the manufacturers of the vaccines had already determined similar values ​​in their studies.” With conventional vaccines, such as against polio or measles, the number of serious side effects is significantly lower.

Serious side effects are symptoms that last for weeks or months and require medical attention. These include muscle and joint pain, heart muscle inflammation, excessive reactions of the immune system and neurological disorders, i.e., impairments of the nervous system. “Most side effects, including severe ones, subside after three to six months, 80% heal. But unfortunately there are also some that last much longer,” reports Professor Matthes. …

“In view of around half a million cases with serious side effects after Covid vaccinations in Germany, we doctors have to take action,” emphasises Prof. Matthes, who, in addition to his work at the Berlin Charité, is on the board of several medical societies and has been systematically examining the effects of drugs for years. “We have to come to therapy offers, discuss them openly at congresses and in public without being considered anti-vaccination.”

Worth reading in full.

Lancet Vaccine Study Author Says Her Data Show “Danger Signal” of Vaccine Heart Deaths – But the “Powers” Don’t Want to Know

The lead author of a pre-print study in the Lancet examining all-cause mortality in the Covid vaccine trials has said that her work shows a “potential danger signal” for heart-related deaths connected to the mRNA vaccines that “warrants further scrutinisation”.

Speaking to UnHerd‘s Freddie Sayers, Professor Christine Stabell-Benn from the University of Southern Denmark added that there is “major pushback” to her efforts to investigate the effects of vaccines on all-cause mortality and many regulators and companies simply don’t want to know.

While stressing that the numbers in her study are often too small to provide statistical significance and ground firm conclusions, Prof. Stabell-Benn observes that “there is an overweight of cardiovascular deaths in the Pfizer group” which is “a potential danger signal that warrants further scrutinisation”.

Addressing the wider context of safety signals from the mRNA vaccines, she adds (from 22’50”):

I think there are danger signals in relation to cardiovascular deaths and diseases. We know that now with certainty for the mRNA vaccines with respect to myocarditis and pericarditis. But also anecdotally, I would say there are reports of cardiovascular deaths which I think deserve further scrutinisation. This is just a piece in the puzzle, but it adds to the evidence that suggests this is something which should be investigated further for the mRNA vaccines.

Spike in Deaths Concurrent With Vaccinations Must Be Investigated by Authorities, Study Says

Authorities should “comprehensively” investigate a spike in deaths in Cyprus during 2021 that is not explained by COVID-19 but occurred concurrently with the vaccination campaign, a study has concluded.

The peer-reviewed study in the journal Cureus analysed information reported by the Cyprus Ministry of Health to the European Statistical Office (Eurostat), which includes weekly all-cause mortality for 2016-2021, and data collected by the European Centre for Disease Prevention and Control regarding daily reported COVID-19 infections and deaths.

The researchers observed an increase of 9.7% in all-cause mortality in Cyprus in 2021 compared to 2020, with an overall mortality increase of 16.5% in 2021 compared to the mean mortality of the previous five years. In particular, they found a sharp increase over the third and fourth quarters of 2021 – see charts above, on which I have highlighted the key areas.

Covid Vaccines Impair Immune Response to Infection, U.S. Government Study Shows

A pre-print study (not yet peer-reviewed) by U.S. Government researchers shows vaccinated people produce a less comprehensive immune system response following SARS-CoV-2 infection than unvaccinated people.

The researchers examined data from the Moderna Covid vaccine trial and found that, compared to unvaccinated controls, vaccinated participants produced far fewer N-antibodies. These are antibodies against the nucleocapsid protein inside the virus particle, in contrast to S-antibodies against the spike protein that the vaccines target. N-antibodies were detected in 40% (21 of 52) of infected vaccine recipients versus 93% (605 of 648) of placebo recipients. This means those infected after being vaccinated produced N-antibodies at less than half the rate of the unvaccinated.

The researchers found that N-seroconversion (producing N-antibodies following infection) was more likely for infections with higher viral loads. So they checked to see if the difference was due to the vaccinated having milder infections with lower viral loads owing to the vaccine. They found that it wasn’t: for the same viral load the unvaccinated were around 14 times (13.67, 95% confidence interval 5.17-36.16) more likely to have detectable N-antibodies following infection than the vaccinated. Look at the contrasting curves below: the yellow unvaccinated curve is much higher than the blue vaccinated curve, showing that for any given viral load (x-axis) the probability of detecting N-antibodies following infection (y-axis) is much lower for vaccinated than unvaccinated.