Pfizer Confidential Document Attached
Time to Share.
You know what to do with this substack.
I am attaching for you the ‘COVID-19 mRNA vaccine (nucleoside modified) Periodic Safety Update Report (PSUR) 1 Reporting Period 19 December 2020 through 18 June 2021’
Periodic Safety Update Report #1
Active Substance: COVID-19 mRNA vaccine (nucleoside modified)(NBT162b2)
ATC CODE: J07BX03
Authorisation Procedure in the EU: Centralized
Date of this Report: 19 August 2021
This is a data rich document, with the following signals were addressed:
- Signals determined not to be risks:
Seizure, Thromboembolic events, Delayed skin reaction, Delayed syncope, Eye pain and eye swelling, Herpes zoster including ophthalmic herpes zoster, Appendicitis, Hearing loss and tinnitus, Extensive swelling of the limbs, Reaction associated with dermals fillers, Injections site pruritis, Insomnia, Overdose, Deaths (including elderly or frail individual), Facial nerve palsy.
It is odd to me that these signals be observed and then deemed, or determined, as the verb is chosen, not to be risks. So much of our current society is governed by language evolution. This is no differed. It is ‘determined’ not to be risks.
The Signals determined to be risks:
Dizziness for the process of vaccination rather than the vaccine substrate, Hyperhidrosis, Night sweats, Asthenia, Lethargy, Decreased appetite, Vaccine stress-related responses, Tachycardia, Diarrhea, Pain in extremity (Arm), Anaphylaxis, Vomiting, Hyper sensitivity, other than anaphylaxis, Paraesthesia.
The Signals Pfizer indicates is Ongoing are as follows:
Immune thrombocytopenia, Trigeminal neuralgia, Myocarditis and pericarditis, Hypertensive crisis with intracranial haemorrhage.
Pfizer also noted:
During the reporting period, monitoring was requested or was proposed by the MAH in previous Summary Monthly Safety Reports (SMSRs) for
Lymphopenia, Immune thrombocytopenia, Hearing loss and tinnitus, Hypoglycemia, Serious hypertension, Hemophagocytic syndrome, Serious arrhythmias, Acute ;pancreatis, Acquired hemophilia, and Menstrual disorders.
Pfizer noted that in alignment with the Eruropean Union Risk Management Plan in effect at the beginning of the reporting period, the important identified risk is anaphylaxis, and the important potential risk is vaccine-associated enhanced disease (VAED) including Vaccine-associated enhanced respiratory disease (VAERD); Missing information are use in pregnancy and while breast feeding, Use in immunocompromised patiens, Use in frail patients with co-morbidities (eg, chronic obstructive pulmonary disease, diabetes, chronic neurological disease, cardiovascular disorders), use in patients with autoimmune or inflammatory disorders, Interaction with other vaccines and Long term safety data.
V-Aids is not a thing MSM will say. Yet in the report VAED, and VAERD are acknowledged. I suppose you could if you wanted, reframe VAED or VAERD as long covid.
The list of safety concerns was updated with the inclusion of myocarditis and pericarditis as important identified risk and the pharmocovigilance plan was consequently updated on August 6, 2021.
How many individuals continued to boost or obtain original 2 dose series after this date in order to meet a travel or employment requirement. How many mRNA infectible factories are being mounted world wide as living horror-testaments, to the immateriality of the suffering imposed on humans. Are lives, subservient to profit, greed, control, and outcome? Outcome being anything with a 2% reporting incidence that is not a concern. Not a concern can be for any number of reasons. The one most top of mind as I write, is that those imposing this are simply not concerned with causing or even mandating death, or injury. It is not a concern. It is no longer a signal by virtue of the Investigator, it is resolved (having a known outcome), or it is not a concern for the Sponsor
Pfizer closed and categorized as no risk DLP, and Immune thrombocytopenia.
They closed as non-validated signals Trigeminal neuralgia and Hypertensive crisis with intracranial haemorrhage.
Pfizer states that the benefit-risk profile of BNT162b2 remains ‘favorable’. Yet what follows is a true crime syndicate of events that are disturbing to the core.
Vaccine Injured individuals and their families should want to review thoroughly along with the physicians asking them to update their injections.
If you are inclined to print the report and distribute it at each pharmacy in pediatrician in your area, you may be doing a service. You may want to serve the reports on your members of council, your mayors, your place of employment. You may want to hand it out in day cares, faith groups. You may want to spend some money and print and drop them off at your local media. You may want to give it to firefighters, Paramedics, doctors and nurses. You may want to give it physically to teachers, bar tenders, uber drivers. You may especially want to go to MPs and MPP and demand that they retract their investments in future plants. Why should your tax paying dollars go towards the bricks and motor of so much future death and destruction.
You may in fact just want to burn out the cartridges in the print shops and do mass distribution. You can of course send by email. But there is nothing so satisfying as handing the printed document.
When you examine the tables of Cumulative and Interval Number of administered Doses you will notice a sharp decline in the numbers from Dose 1 and Dose 2. One wonders about the consistency of this across age groups and countries. Are adverse events epidemiologically transparent with this consistent representation? If you have been hurt with the first dose. Would you get the next one?
In table 5 stratification of the adverse events by sex establishes significantly more adverse events in women at a ratio of 3 adverse event in women for every 2 in men.
Would you conclude a dose dependency and weight ratio is relevant? Given the adult dose was the same irrespective of sex? What about small women, would they suffer even more?
The Age group that suffered the most adverse events was 31-50, next 51-64, followed by 18-30, then over 75, and 65-74. Troubling was the under 17 events given how few received the shots.
In the clinical Trial data:
SAES assessed as related to BNT162: Acute myeloid leukaemia, anaphylactoid reaction, Cystisis, Hyperthyroidism, Myalgia, Myocardial infarction, Polymyalgia rheumatica, Portal vein thrombosis, Thyroid mass
There is a great number of events listed in the document and Pfizer is able to dismiss some as being ‘resolved’. Another method is to note that the events were not considered to be related to the vaccine by either the ‘Investigator or Sponsor’. No conflicts here. Consideration is not fact. It is another word.
If greater than 2% of people report an event discounting should not occur.
The thoroughness of the documented horror details, truly crimes against the recipients of these vaccines.
There is substantial data about comorbidities which may have also been relevant for informed consent.
In 6.3.1.3 Pfizer acknowledges that the majority of adverse events were reported for female patients. And the greatest number of events occurred in the 31-50 age group.
Resolved in that paragraph means WHERE THE OUTCOME WAS KNOWN. Having a known outcome is not cured and also does not mean the original signal should be dismissed.
Fatalities increased with co-morbidities.
This was the opposite of the advice given at the time. You were told you were more at risk of the disease with comorbidities, so get the ‘cure’. In fact it is apparent that co morbidities hurt your chances of surviving the vaccine and increased the chances of suffering an adverse event from the vaccine.
Thank you!! 🙏🏻
Thank you for your hard work 😓 on this