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Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines.
McMurry, Reid; Lenehan, Patrick; Awasthi, Samir; Silvert, Eli; Puranik, Arjun; Pawlowski, Colin; Venkatakrishnan, A J; Anand, Praveen; Agarwal, Vineet; O'Horo, John C; Gores, Gregory J; Williams, Amy W; Badley, Andrew D; Halamka, John; Virk, Abinash; Swift, Melanie D; Carlson, Katie; Doddahonnaiah, Deeksha; Metzger, Anna; Kayal, Nikhil; Berner, Gabi; Ramudu, Eshwan; Carpenter, Corinne; Wagner, Tyler; Rajasekharan, Ajit; Soundararajan, Venky.
  • McMurry R; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Lenehan P; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Awasthi S; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Silvert E; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Puranik A; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Pawlowski C; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Venkatakrishnan AJ; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Anand P; nference Labs, 2nd Floor, 22 3rd Cross Rd, Murgesh Pallya, Bengaluru, Karnataka 560017, India.
  • Agarwal V; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • O'Horo JC; Mayo Clinic, Rochester, MN 55902, USA.
  • Gores GJ; Mayo Clinic, Rochester, MN 55902, USA.
  • Williams AW; Mayo Clinic, Rochester, MN 55902, USA.
  • Badley AD; Mayo Clinic, Rochester, MN 55902, USA.
  • Halamka J; Mayo Clinic, Rochester, MN 55902, USA.
  • Virk A; Mayo Clinic, Rochester, MN 55902, USA.
  • Swift MD; Mayo Clinic, Rochester, MN 55902, USA.
  • Carlson K; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Doddahonnaiah D; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Metzger A; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Kayal N; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Berner G; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Ramudu E; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Carpenter C; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Wagner T; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Rajasekharan A; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
  • Soundararajan V; nference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Med (N Y) ; 2(8): 965-978.e5, 2021 08 13.
Article in English | MEDLINE | ID: covidwho-1294062
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Med (N Y) Year: 2021 Document Type: Article Affiliation country: J.medj.2021.06.006

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Med (N Y) Year: 2021 Document Type: Article Affiliation country: J.medj.2021.06.006