About That CDC Stroke "Safety" Signal We All Detected Last Year: America Suffered the Cost of Vaccine Risk, Injury & Death Denialism.

First of all, it's a signal of risk, not safety. Second, we detected the signal over a year ago, long before the CDC. They appear now to have lost the signal. How many strokes could have been averted?

This is a compendium of useful resources - evidence - that proves that the signal of stroke was present early on and persisted through the process to “pharmacovigilance”.

May 2021

Dr. Gregory Michael

From Seneff et al (May, 2021): “Dr. Gregory Michael, an obstetrician in Miami Beach, died of a cerebral hemorrhage 16 days after receiving the first dose of the Pfizer/BioNTech COVID-19 vaccine. Within three days of the vaccine, he developed idiopathic thrombocytopenic purpura (ITP), an autoimmune disorder in which the immune cells attack and destroy the platelets. His platelet count dropped precipitously, and this caused an inability to stop internal bleeding, leading to the stroke, as described in an article in the New York Times (Grady and Mazzei, 2021). The New York Times followed up with a second article that discussed several other cases of ITP following SARS-CoV-2 vaccination (Grady, 2021), and several other incidences of precipitous drop of platelets and thrombocytopenia following SARSCoV-2 vaccination have been reported in the Vaccine Adverse Event Reporting System (VAERS).”

October 2021

Dr. Blaylock, October 2021 - Covid-19 pandemic: What is the truth? Surg Neurol. In 2021 doi: 10.25259/SNI_1008_2021. eCollection 2021.

“These vaccines can also trigger seizures, strokes, and even neuropsychiatric disorders. Keep in mind that in some cases these disorders do not appear for years or even decades. Dr. Peter McCullough, a professor of internal medicine and cardiology, cited a case in which a woman lost all memory after receiving the first vaccine dose.[26] He also told of a fully vaccinated woman who lost her baby after breastfeeding. The child died of a thrombotic/hemorrhagic episode.”

Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720447/

Dec 2021

A comment on Steve Kirsch’s newsletter, Dec, 2021:

“Ancedotally (sic), I was in the ER a couple of weeks ago. Hospital beds in the area were full of stroke, heart attack, and clotting patients. This nurse offered this when i asked. I was, under protest, being worked up for heart attack and clotting because i casually mentioned chest pain in a telehealth appointment. I had a cold. I tried to walk it back and they wouldn't let me. D-dimer, ekg, traponin (sic) test. I am 41, low bmi, exercise 5 times a week, take no medications, no history of heart issues. I was like, uh, you guys seeing a lot of heart attacks? They were like, OMG SO MANY. And strokes too, and blood clots. They just the last two, i did not prompy(sic) them.”

A paragraph from Tobey McDonald’s Substack on December 6, 2021

“4. Vaccine mandates are a way to purge Republicans from the military, fire departments, police departments, schools & universities, and the medical field — and give those jobs to loyal Democrats, many of whom will die shortly thereafter from vaccine-induced heart attacks, blood clots, and strokes. It’s diabolically clever for about five minutes then it backfires and the entire system begins to collapse (this has already begun). It’s the most audacious power grab by one political party in U.S. history and everyone knows this. The 30% to 50% of the U.S. population who have been mistreated in this way are furious and they are looking to Republican elected officials to fight for them.”

Dear Republican elected officials: thank you *and* you need to do so much more

Mention of strokes in Celia Farber’s Substack, Dec 9, 2021:

Thomas Renz' Reveal: Medicare Data Doesn't Lie: Shows 48,465 Deaths Related To Shots

Popular Rationalism, Dec, 2021

As Evidence of Pathogenic Priming Mounts, Calls for New Medical Approaches to Mute Autoimmunity Must Be Addressed

Official Vaccine “Science” Failed Us… And Continues to Do So

Wong et al (2021), an FDA report, wrote:

“As of June 25, 2021 (data through June 12, 2021), the observed number of deep vein thrombosis (DVT) and non-hemorrhagic stroke (NHS) events following Pfizer-BioNTech and Moderna vaccination exceeded the pre-specified number of expected events…”

Why did they not act on this signal then?

Meanwhile, most of the other people in charge could not detect risk of stroke in their data. For example, from France:

NOVEMBER 2021

Jabagi et al., 2021 https://jamanetwork.com/journals/jama/fullarticle/2786667

Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older. JAMA. Published online November 22, 2021. doi:10.1001/jama.2021.21699 
The BNT162b2 mRNA vaccine (Pfizer-BioNTech) was the first SARS-CoV-2 vaccine authorized and most widely used in older persons in France. Although no increases in cardiovascular events were reported in the phase 3 trials,1 questions emerged once the vaccine was used on a large scale because older people were underrepresented in the trials. We evaluated the short-term risk of severe cardiovascular events among French people aged 75 years or older after the administration of the BNT162b2 mRNA vaccine. Methods This population-based study used the French National Health Data System linked to the national COVID-19 vaccination database. Eligible participants were all persons unvaccinated or vaccinated with the BNT162b2 vaccine, aged 75 years or older, admitted to the hospital between December 15, 2020, and April 30, 2021, for acute myocardial infarction, hemorrhagic stroke, ischemic stroke, or pulmonary embolism (diagnoses identified using the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes) (Table 1 and eTable in the Supplement). We undertook within-person comparisons using a self-controlled case series method adapted to cardiovascular event–dependent exposures and high–event-related mortality that can cancel or defer subsequent vaccination or increase short-term mortality2 (eMethods in the Supplement). Only exposures preceding the event were considered. Exposure risk intervals were the 1 through 14 days following each of the 2 vaccine doses. The exposure risk interval was further subdivided into days 1 through 7 and 8 through 14. Except for the vaccination day, the remaining periods were regarded as nonrisk periods. Unvaccinated persons were included to account for temporal effects. Unbiased estimating equations were used to calculate the relative incidence (RI) adjusted for temporality (in 7-day increments) to consider any changes in background rates of both events and vaccination. All analyses were performed using the SCCS package in R, version 3.6.1. A 95% CI around the RI that did not include 1 defined statistical significance. The research group has permanent regulatory access to the data from the French National Health Data System (French decree No. 2016-1871 of December 26, 2016, on the processing of personal data called National Health Data System and French law). No informed consent was required because data are anonymized. Results As of April 30, 2021, nearly 3.9 million persons 75 years or older had received at least 1 dose of the BNT162b2 vaccine and 3.2 million had received 2 doses. Over the observation period, 11 113 persons 75 years or older were hospitalized for an acute myocardial infarction, 17 014 for an ischemic stroke, 4804 for a hemorrhagic stroke, and 7221 for pulmonary embolism, of whom 58.6%, 54.0%, 42.7%, and 55.3%, respectively, received at least 1 dose of the vaccine (Table 1). In the 14 days following either dose, no significant increased risk was found for any outcome: the RI for myocardial infarction for the first dose was 0.97 (95% CI, 0.88-1.06) and for the second dose, 1.04 (95% CI, 0.93-1.16); for ischemic stroke for the first dose, 0.90 (95% CI, 0.84-0.98) and for the second dose, 0.92 (95% CI, 0.84-1.02); for hemorrhagic stroke for the first dose, 0.90 (95% CI, 0.78-1.04) and for the second dose, 0.97 (95% CI, 0.81-1.15); or for pulmonary embolism for the first dose, 0.85 (95% CI, 0.75-0.96) and the second dose, 1.10 (95% CI, 0.95-1.26) (Table 2). No significant increase for any of the cardiovascular events was observed in the 2 subdivided exposure intervals (1-7 days and 8-14 days) (Table 2). Discussion In this nationwide study involving persons aged 75 years or older in France, no increase in the incidence of acute myocardial infarction, stroke, and pulmonary embolism was detected 14 days following each BNT162b2 mRNA vaccine dose. Israeli and US studies reported that persons receiving the BNT162b2 vaccine were not at increased risk of myocardial infarction, pulmonary embolism, or cerebrovascular events in the 42 days3 and 21 days4 following vaccination. Based on a self-controlled case-series design that compensates for the lack of randomization by eliminating the effect of time-invariant confounding factors, this study provides further evidence regarding the risk of serious cardiovascular adverse events in older people. Limitations of the study include the possibility of residual time-dependent confounding. Further investigations are needed to measure these risks in younger populations and for other types of vaccines against SARS-CoV-2. Section Editors: Jody W. Zylke, MD, Deputy Editor; Kristin Walter, MD, Associate Editor.Article InformationCorresponding Author: Marie Joelle Jabagi, PharmD, PhD, EPI-PHARE, 143-147 Boulevard Anatole France, F-93285 Saint-Denis CEDEX (marie-joelle.jabagi@ansm.sante.fr).

Those who suffered through the various ACIP and VRBPAC meetings and watch report after report miss the risk signals we saw felt like we were watching a massive train collision.

And guess what? After seeing a significant signal, CDC and FDA relied on their data fixers who analyze the VSD data to lose it.

https://www.thehealthsite.com/news/covid-19-vaccines-can-cause-sudden-cardiac-deaths-warns-expert-calls-for-its-withdrawal-from-market-942361/

“CDC and FDA find no increased risk of ischemic stroke for elderly who get Pfizer’s bivalent booster”

https://thehill.com/policy/healthcare/3812618-cdc-and-fda-find-no-increased-risk-of-ischemic-stroke-for-elderly-who-get-pfizers-bivalent-booster/

We will be revisiting this issue with new analyses.

Some citations

Fraiman, J., Erviti, J., Jones, M., Greenland, S., Whelan, P., Kaplan, R. M., & Doshi, P. (2022). Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine, 40(40), 5798-5805.

Abstract. Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Seneff and Nigh, 2021. Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19 IJVTPR https://ijvtpr.com/index.php/IJVTPR/article/view/23

Grady, D. & Mazzei, P. (2021). Doctor's Death After COVID Vaccine Is Being Investigated. New York Times Jan. 12. https://www.nytimes.com/2021/01/12/health/covid-vaccine-death.html

Grady, D. (2021). A Few Covid Vaccine Recipients Developed a Rare Blood Disorder. New York Times Feb. 8. https://www.nytimes.com/2021/02/08/health/immune-thrombocytopenia-covid-vaccine-blood.html

Demasi, M. (2022). FDA oversight of clinical trials is “grossly inadequate,” say experts. bmj, 379.

Fenton N, Neil M (2022) The Devil's Advocate: An Exploratory Analysis of 2022 Excess Mortality https://wherearethenumbers.substack.com/p/the-devils-advocate-an-exploratory

Gill JR, Tashjian R, Duncanson E. Autopsy Histopathologic Cardiac Findings in 2 Adolescents Following the Second COVID-19 Vaccine Dose. Arch Pathol Lab Med [Internet]. 2022 Aug 1;146(8):925–9. Available from: http://dx.doi.org/10.5858/arpa.2021-0435-SA https://meridian.allenpress.com/aplm/article/146/8/925/477788/Autopsy-Histopathologic-Cardiac-Findings-in-2

Schwab C, Domke LM, Hartmann L, Stenzinger A, Longerich T, Schirmacher P. Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination. Clin Res Cardiol [Internet]. 2022 Nov 27;1–10. Available from: http://dx.doi.org/10.1007/s00392-022-02129-5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9702955/

Schneider J, Sottmann L, Greinacher A, Hagen M, Kasper HU, Kuhnen C, et al. Postmortem investigation of fatalities following vaccination with COVID-19 vaccines. Int J Legal Med [Internet]. 2021 Nov;135(6):2335–45. Available from: http://dx.doi.org/10.1007/s00414-021-02706-9 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8482743/

Sessa F, Salerno M, Esposito M, Di Nunno N, Zamboni P, Pomara C. Autopsy Findings and Causality Relationship between Death and COVID-19 Vaccination: A Systematic Review. J Clin Med Res [Internet]. 2021 Dec 15;10(24). Available from: http://dx.doi.org/10.3390/jcm10245876 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8709364/

“As of June 25, 2021 (data through June 12, 2021), the observed number of deep vein thrombosis (DVT) and non-hemorrhagic stroke (NHS) events following Pfizer-BioNTech and Moderna vaccination exceeded the pre-specified number of expected events…”

Wong HL, Zhou CK, Tworkoski E, et al. Assessment of acute myocardial infarction, pulmonary embolism, disseminated intravascular coagulation and immune thrombocytopenia following covid-19 vaccination. FDA, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology. 2021. https://bestinitiative.org/wp-content/uploads/2021/09/C-19-Vaccine-Safety-AMI-PE-DIC-ITP-Protocol-2021.pdf