TY - JOUR
T1 - Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines
AU - McMurry, Reid
AU - Lenehan, Patrick
AU - Awasthi, Samir
AU - Silvert, Eli
AU - Puranik, Arjun
AU - Pawlowski, Colin
AU - Venkatakrishnan, A. J.
AU - Anand, Praveen
AU - Agarwal, Vineet
AU - O'Horo, John C.
AU - Gores, Gregory J.
AU - Williams, Amy W.
AU - Badley, Andrew D.
AU - Halamka, John
AU - Virk, Abinash
AU - Swift, Melanie D.
AU - Carlson, Katie
AU - Doddahonnaiah, Deeksha
AU - Metzger, Anna
AU - Kayal, Nikhil
AU - Berner, Gabi
AU - Ramudu, Eshwan
AU - Carpenter, Corinne
AU - Wagner, Tyler
AU - Rajasekharan, Ajit
AU - Soundararajan, Venky
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/8/13
Y1 - 2021/8/13
N2 - Background: As the coronavirus disease 2019 (COVID-19) vaccination campaign unfolds, it is important to continuously assess the real-world safety of Food and Drug Administration (FDA)-authorized vaccines. Curation of large-scale electronic health records (EHRs) enables near-real-time safety evaluations that were not previously possible. Methods: In this retrospective study, we deployed deep neural networks over a large EHR system to automatically curate the adverse effects mentioned by physicians in over 1.2 million clinical notes between December 1, 2020 and April 20, 2021. We compared notes from 68,266 individuals who received at least one dose of BNT162b2 (n = 51,795) or mRNA-1273 (n = 16,471) to notes from 68,266 unvaccinated individuals who were matched by demographic, geographic, and clinical features. Findings: Individuals vaccinated with BNT162b2 or mRNA-1273 had a higher rate of return to the clinic, but not the emergency department, after both doses compared to unvaccinated controls. The most frequently documented adverse effects within 7 days of each vaccine dose included myalgia, headache, and fatigue, but the rates of EHR documentation for each side effect were remarkably low compared to those derived from active solicitation during clinical trials. Severe events, including anaphylaxis, facial paralysis, and cerebral venous sinus thrombosis, were rare and occurred at similar frequencies in vaccinated and unvaccinated individuals. Conclusions: This analysis of vaccine-related adverse effects from over 1.2 million EHR notes of more than 130,000 individuals reaffirms the safety and tolerability of the FDA-authorized mRNA COVID-19 vaccines in practice. Funding: This study was funded by nference.
AB - Background: As the coronavirus disease 2019 (COVID-19) vaccination campaign unfolds, it is important to continuously assess the real-world safety of Food and Drug Administration (FDA)-authorized vaccines. Curation of large-scale electronic health records (EHRs) enables near-real-time safety evaluations that were not previously possible. Methods: In this retrospective study, we deployed deep neural networks over a large EHR system to automatically curate the adverse effects mentioned by physicians in over 1.2 million clinical notes between December 1, 2020 and April 20, 2021. We compared notes from 68,266 individuals who received at least one dose of BNT162b2 (n = 51,795) or mRNA-1273 (n = 16,471) to notes from 68,266 unvaccinated individuals who were matched by demographic, geographic, and clinical features. Findings: Individuals vaccinated with BNT162b2 or mRNA-1273 had a higher rate of return to the clinic, but not the emergency department, after both doses compared to unvaccinated controls. The most frequently documented adverse effects within 7 days of each vaccine dose included myalgia, headache, and fatigue, but the rates of EHR documentation for each side effect were remarkably low compared to those derived from active solicitation during clinical trials. Severe events, including anaphylaxis, facial paralysis, and cerebral venous sinus thrombosis, were rare and occurred at similar frequencies in vaccinated and unvaccinated individuals. Conclusions: This analysis of vaccine-related adverse effects from over 1.2 million EHR notes of more than 130,000 individuals reaffirms the safety and tolerability of the FDA-authorized mRNA COVID-19 vaccines in practice. Funding: This study was funded by nference.
KW - BNT162b2
KW - COVID-19
KW - COVID-19 vaccines
KW - Translation to population health
KW - mRNA-1273
KW - propensity score matching
KW - real world analysis
KW - vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=85110410124&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85110410124&partnerID=8YFLogxK
U2 - 10.1016/j.medj.2021.06.006
DO - 10.1016/j.medj.2021.06.006
M3 - Article
C2 - 34230920
AN - SCOPUS:85110410124
SN - 2666-6359
VL - 2
SP - 965-978.e5
JO - Med
JF - Med
IS - 8
ER -