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COVID-19 vaccines adverse events: myocarditis, pericarditis, etc. (99 million people, not US) – Feb 2024


COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

Vaccine https://doi.org/10.1016/j.vaccine.2024.01.100
K. Faksova a, D. Walsh b c, Y. Jiang b c, J. Griffin c, A. Phillips d, A. Gentile e, J.C. Kwong f g h, K. Macartney d i, M. Naus j n, Z. Grange k, S. Escolano l, G. Sepulveda m, A. Shetty m, A. Pillsbury d, C. Sullivan k, Z. Naveed j n, N.Z. Janjua j n, N. Giglio e, J. Perälä o, S. Nasreen f p x…A. Hviid a w

This summary is NOT in the PDF
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Major color groups used for different pharmas:
   Red = Moderna, Blue = Pfizer, Amber = AstraZeneca
Shades within the groups related to different doses of the particular pharma's "vaccine"

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Background
The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.

Methods
Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.

Results
Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.

Conclusion
This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
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URL = https://www.globalvaccinedatanetwork.org/

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Dr. talked with authors then made video: study did not look at long-COVID problems

Drbeen 39 minutes


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Attached files

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