This post is by our South American correspondent.
A Water into Wine miracle occurred in Buenos Aires in October 2020. A 66 year old volunteer, number 12315632 in Pfizer’s Comirnaty vaccine trial, had received his second vaccination of BNT162b2 (30 μg) on the nineteenth of September in the city’s Hospital Militar.
Twenty-nine days later he was admitted to hospital with chest pain.
According to the Adverse Events file released by FDA to PHMPT, this man had a serious adverse event of “Pericarditis” grade 2, which clearly someone in the trial process deemed not related to the vaccine. It apparently did not resolve.
Then a miracle occurred.
Somehow the diagnosis of pericarditis at least, maybe not the underlying condition, became “suspected covid-19”. The Suspected Covid-19 diagnosis survived three negative covid swab tests. Pfizer concurred with this view of the investigator or the treating doctor or someone who was involved in assembling the ‘facts’ that Suspected Covid-19 – Suspected is the key word – was the diagnosis.
(DSM could be doubled in size if we add Suspected to everything and perhaps doubled again for Suspected Martian disorder or whatever related entities we can conjure up. The link to DSM here is very deliberate as readers are about to find out).
The Narrative for this is reproduced below. It comes from a Narrative (Sensitive) file – a different file to the Adverse Events file – that says:
Subject C4591001 1231 12315632, a 66-year-old white male with no reported medical history, received Dose 1 on 31 Aug 2020 and Dose 2 on 19 Sep 2020 (Day 20). The subject reported suspected (but not confirmed) COVID-19 on 17 Oct 2020, 28 days after receiving Dose 2.
On 17 Oct 2020 (Day 48) the subject experienced left shoulder and arm pain. On 18 Oct 2020 (Day 49), at 01:00 AM the subject experienced chest pain and dyspnea and called the emergency system. He was taken to the emergency room by ambulance where they performed: electrocardiogram with no ischemic changes, chest x-ray with unknown results, chest computerized tomogram that showed pneumonia of unknown localization. At the time of reporting the subject had presented with a temperature of 38°C. Blood/laboratory tests were done but results were unreported.
In accordance with the hospital COVID-19 pandemic protocol the subject had a SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) swab. The date of discharge from hospital is unknown, however, the site received a discharge summary on 20 Oct 2020 (Day 51) stating the result of the SARS-CoV2 RT-PCR swab was negative. The swab taken for the purposes of the study and analyzed at the central laboratory was also negative. An additional SARS-CoV-2 test performed locally on 28 Oct 2020 was also negative. The cause of the potential COVID-19 illness remains unknown as no other microbiological studies were performed. The suspected (but not confirmed) COVID-19 illness was ongoing at the time of the last available report. In the opinion of the investigator, there was no reasonable possibility that the suspected COVID-19 was related to the study intervention or clinical trial procedures. Pfizer concurred with the investigator’s causality assessment.
As we have reported, Augusto Roux was on the receiving end of a similar miracle, a short while before. His hospital-confirmed vaccine-induced adverse reaction of pericarditis similarly disappeared into “suspected covid” and then “severe anxiety”. At the moment it looks like iTRIALS team led by Fernando Polack were responsible for this transformation.
Fernando and Stephen
We have written to Drs Polack and Thomas, lead investigators for this trial.
Dear Drs Polack and Thomas]
The writing of papers like the ones in the NEJM on which you are first authors is a well-oiled business. I realise that you did not have access to the trial data, and likely may not know the answer to the following, or if you do know the answer you may not be in a position to help me.
I am copying FDA and ANMAT into this email for this reason, without any expectation regulatory bureaucrats are likely to do anything soon.
My query concerns a second instance of a BNT162b2 vaccinated patient from Argentina who is recorded as developing an adverse event of pericarditis 28 days after receiving his second dose.
The volunteer’s trial number is 12315632.
Page 996 of the narrative account of this event states that he had “probable covid-19 illness” (despite three negative swab tests) with no mention of pericarditis.
The pericarditis is documented in page 286 of the Clinical Safety Report. It is also documented in an Adverse Events document. The mention on p 286 of the Clinical Safety report tells us that:
Pericarditis There was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention. A narrative for this event is provided (see Section 220.127.116.11.4.4 [Subject C4591001 1231 12315632]).
This reference to a narrative takes us back to the account noted above, which has no mention of pericarditis.
I imagine most people reading these entries would view pericarditis as a more likely diagnosis than probable Covid-19 illness in this case. It is also difficult to see a basis for not making a possible linkage to the vaccine in an event that is coded as Severe, toxicity grade 2.
The clinical information in the narrative summary about this volunteer’s hospital admission seems inadequate. It looks possible that the data for #12315632 might have been altered.
This case seems a replay of what happened to volunteer 12312982, Augusto Roux, whose clinically confirmed adverse event of illness with pericarditis has disappeared.
Mr Roux seems to have had a raw deal from his participation in this trial, as perhaps this other volunteer has also. The consent form for the trial indicates that Mr Roux and this latest volunteer would get clinical support from Pfizer in the event of anything going wrong. This didn’t happen in Mr Roux’s case.
One plausible explanation for the disappearance of injuries to these two volunteers is that keeping them in place would jeopardise the rapid approval of this vaccine – this seems to be direct conflict with Pfizer and i-Trials obligations in this trial.
Quite aside from the injury to this volunteer, as with Mr Roux, the conflicting documents cause their own problem. Knowing the sequence in which they were assembled and who they were written by might help. I realise there were a range of ‘fact’ checkers from Pfizer and iTrials and Icon and perhaps others involved.
Can you send me the back and forth between these parties or otherwise help to reconcile these incompatible trial documents? If this can be done for this volunteer, I would appreciate a similar sequence of documents and back and forth with dates and times in the case of Augusto Roux.
I realise this trial appears to have been governed by military secrecy needs in both Argentina and the United States. I imagine you might both be under orders to say nothing. The regulators may be similarly constrained.
I have no idea whether Data Safety Monitoring Boards are also constrained in this respect and for this reason I have included the DSMB for this trial in this correspondence also.
At the end of the day, in military speak, there is an obligation to troops who have volunteered in this War, whose contracts essentially say they will be given the best possible treatment, who were provided with Dr Polack’s day and night time phone numbers in the contract they signed, but who, in this case, cannot get the right treatment, never mind the best treatment, if it is not possible to acknowledge the source and nature of their injuries.
These volunteers are being treated as soldiers were in the days before the American Civil War.
This email will be posted publicly. I will happily also post any responses I receive from any party copied in here.
Jorge and Miracles
On August 18, 1996 in the Church of Santa María in Almagro, Buenos Aires, Argentina, the start of a miracle occurred. A consecrated Host (bread) had been desecrated on a candle holder in the back of the Church. Unable to consume the Host, the priest, Fr. Pezet put it into a glass of water into the tabernacle so that it would dissolve.
When he opened the tabernacle on August 26, he saw that the Host had been transformed into a piece of bloody tissue which was much larger than the original Host. When Fr. Pezet informed Archbishop Bergoglio of the occurrence, the archbishop asked him to have the Host professionally photographed.
After three years, the bloody tissue had not decomposed. Archbishop Bergoglio asked that the bloody tissue be scientifically examined. The analyzed material has been shown to be a fragment of the heart muscle found in the wall of the left ventricle close to the valves.
Science and Faith
According to Fr. Robert Spitzer, a Jesuit priest and doctor of astrophysics, a recent Jesuit survey has revealed that, far and away, the greatest cause today for people losing their faith and becoming either agnostic or atheistic in our country (The US) is the perceived conflict between faith and science. In fact 93% of those who lose their faith say the claims of religion do not hold up to the scrutiny of what we know through modern science. Put another way, these individuals have simply shifted their faith in God to faith in science as the definitive way of knowing truth.
The Church position is that faith and reason are simply different ways of coming to know truth, either through divine revelation or through careful observation of the created universe. They can never truly be in conflict because God, who is The Truth, is both the creator of the ordered, observable universe and the very author of science. However, to try to reach those who have lost their faith in this way and who perhaps do not share the Church’s view on truth, Spitzer has suggested featuring miracles of the Church that have undergone intense scientific scrutiny, where “the finger of God” has stumped all scientific explanation. One definition of “miracle” is “an event that is not explicable by natural or scientific laws and is therefore considered to be the work of divine agency”. Understood in this way, the existence of miracles should lead one to faith.
The first point to note of course is that Robert Spitzer was the architect of the modern DSM system.
Second, what gets called science these days is a ghost-written literature, a great deal of which is essentially fraudulent, one of whose functions like all organized religions is to keep the people moving together as a herd.
Third, the Bible that Bergoglio claims to adhere to gives a very different message. The Kingdom of God is in everyone you meet. Your job is not to tell them to get vaccinated – Bergoglio was later the first to mandate vaccines. Your job, like a Good Samaritan, is to recognize them when they are injured.
The people who get harmed on a drug or vaccine are the Crack through which the Science gets in. As Spitzer would have been better placed saying – they deserve careful observation of the created universe. They are increasingly, however, as the bible put it, the Stone that the Builders have rejected.
And there are new ‘sciences’ like Harmatology conjured into being to make them disappear,
If Bergoglio wants to reconcile religion and science, rather than meeting up with the Global Elite to plan a post Covid World he should pay more heed to Augusto Roux, Brianne Dressen, volunteer 12315632 and the hundreds of others in this and other vaccine trials that have gone missing – see The Disappeared.
Spitzer seems to be struggling to say science and religion need truth not myth. When it comes to treatment induced injuries, these days both science and religion lean toward myths rather than truth. Bergoglio seems all too keen to reconcile ‘science’ with ‘religion’.