Here's the peer reviewed study mentioned in the tweet Ralph posted above.
mdpi.com
Association of Cerebral Venous Thrombosis with mRNA COVID-19 Vaccines: A Disproportionality Analysis of the World Health Organization Pharmacovigilance Database:
https://www.mdpi.com/2076-393X/10/5/799/htm
Quote:
by Jin Park, Moo-Seok Park, Hyung Jun Kim, and Tae-Jin Song*
Department of Neurology, Seoul Hospital, Ewha Womans University College of Medicine, 260 Gonghang-daero, Gangseo-gu, Seoul 07804, Korea
*Author to whom correspondence should be addressed.
Academic Editors: Antonella Caputo and François Meurens
Vaccines 2022, 10(5), 799; https://doi.org/10.3390/vaccines10050799
Received: 30 March 2022 / Revised: 13 May 2022 / Accepted: 15 May 2022 / Published: 18 May 2022
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Quote:
Abstract
Cerebral venous thrombosis (CVT), a rare thrombotic event that can cause serious neurologic deficits, has been reported after some ChAdOx1 nCoV-19 vaccinations against coronavirus disease 2019 (COVID-19). However, there are few reports of associations between COVID-19 mRNA vaccination and CVT. We retrospectively analyzed CVT occurrence, time of onset after vaccination, outcomes (recovered/not recovered), and death after COVID-19 vaccination from adverse drug reactions (ADR) reports in VigiBase. A disproportionality analysis was performed regarding COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) and the ChAdOx1 nCoV-19 vaccine. We identified 756 (0.07%) CVT cases (620 (0.05%) after BNT162b2 and 136 (0.01%) after mRNA-1273) of 1,154,023 mRNA vaccine-related ADRs. Significant positive safety signals were noted for COVID-19 mRNA vaccines (95% lower end of information component = 1.56; reporting odds ratio with 95% confidence interval (CI) = 3.27). The median days to CVT onset differed significantly between the BNT162b2 and ChAdOx1 nCoV-19 vaccines (12 (interquartile range, 3–22) and 11 (interquartile range, 7–16), respectively; p = 0.02). Fewer CVT patients died after receiving mRNA vaccines than after receiving the ChAdOx1 nCoV-19 vaccine (odds ratio, 0.32; 95% CI, 0.22–0.45; p < 0.001). We noted a potential safety signal for CVT occurrence after COVID-19 mRNA vaccination. Therefore, awareness about the risk of CVT, even after COVID-19 mRNA vaccination, is necessary.
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Quote:
3. Results
On 30 September 2021, 1513 ADR cases (0.09%) of CVT out of 1,730,636 reports were observed for the mRNA-based COVID-19 vaccines (BNT162b2 and mRNA-1273) and the ChAdOx1 nCoV-19 vaccine. Of these, ADRs of CVT were reported as 756 (0.07%) out of 1,154,023 cases for the mRNA-based COVID-19 vaccines (620 (0.05%) for BNT162b2 and 136 (0.01%) for mRNA-1273) and 757 (0.13%) out of 577,124 cases for the ChAdOx1 nCoV-19 vaccine.
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Quote:
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More than 90% of the patients were in serious condition, and 33% did not recover or died. The outcome of death after CVT was significantly higher in patients who received the ChAdOx1 nCoV-19 vaccine than in those who received the mRNA-based COVID-19 vaccines (odds ratio (OR) = 0.32; 95% CI, 0.22–0.45; p < 0.001). In pairwise comparisons of the different types of vaccines, vaccination with ChAdOx1 nCoV-19 more often led to death after CVT than vaccination with BNT162b2 (OR = 0.35; 95% CI, 0.25–0.50; p < 0.001) or mRNA-1273 (OR = 0.18; 95% CI, 0.07–0.44; p < 0.001)
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Figure 2. Disproportionality analysis between mRNA-based vaccines and the ChAdOx1 nCoV-19 vaccine to compare cerebral venous thrombosis occurrence in vaccinated individuals with the entire VigiBase database. The information component (IC) and reporting odds ratio (ROR) were calculated for the disproportionality analysis. In this forest plot, overall COVID-19 vaccines showed significantly positive associations with cerebral venous thrombosis by IC025 (2.01) and ROR025 (5.14).
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Figure 2
at the above link presents both ADR/Adverse Drug Reaction and CVT/Cerebral Venous Thrombosis comparison of Covid Vaccines vs. ALL DRUGS IN THE ENTIRE WHO DATABASE.
These are the numbers for ADR/Adverse Drug Reaction:
Code:
Covid Vaccines: 1,730,636
All Drugs: 27,370,413
These are the numbers for CVT/Cerebral Venous Thrombosis:
Code:
Covid Vaccines: 1,513
All Drugs: 5,615
I don't know how many thousands of different drugs are being tracked in the WHO Database and for how many years.
But the data from the study shows:
1. Covid Vaccines account for 6.32 percent of all ADR/Adverse Drug Reactions in the WHO Database.
2. Covid Vaccines account for 26.95% of all CVT/Cerebral Venous Thrombosis or Vein(s) in the Brain blocked by Blood Clot(s) in the WHO Database.
Imo, THAT is an astounding number.
Breaking the data from Figure 2 in the study out into two categories: Covid Vaccine vs. Non-Covid Vaccine makes this next observation easier to see.
Here's what the data looks like after doing that:
Covid Vaccine ADR and CVT stays the same:
Code:
ADR: 1,730,636
CVT: 1,513
Non-Covid Vaccine ADR and CVT looks like this:
Code:
ADR: 25,639,777
CVT: 4,102
The likelihood of suffering a CVT after a non-Covid Vaccine Adverse Drug Reaction is 4,102/25,639,777 = 1.5999e-4 or 1.5999 in 10,000.
The likelihood of suffering a CVT after a Covid Vaccine Adverse Drug Reaction is 1,513/1,730,636 = 8.7425e-4 or 8.7425 in 10,000.
Put another way:
You are 5.46 times more likely to suffer a CVT after Covid Vaccine Adverse Reaction than after Adverse Reaction for ALL DRUGS IN THE ENTIRE WHO DATABASE THAT AREN'T COVID VACCINES.
Imo, THAT is also an astounding number.
-jp
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