Publications & Presentations
Transparency is a fundamental principle of the operations of the CBER Surveillance Program including the BEST Initiative, Sentinel System, CMS collaboration, and others. Knowledge acquired from the surveillance activities is placed in the public domain. To accomplish this aim, information concerning surveillance activities will be made available on the BEST website and other locations when appropriate.
Most Recent Publications & Presentations Assessments
Title
Date
Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.
Vaccine. 2023 Jul 19 (website)
07/19/2023
Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years
Jama Pediatrics. 2023 May 22 (website)
05/22/2023
Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases
Pathogens. 2023 Mar 01 (website)
03/01/2023
Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion
Drug Saf. 2023 Feb 24 (website)
02/24/2023
Immune globulin usage trends in commercially insured and Medicare populations, 2009-2019
Transfusion. 2023 Feb 20 (website)
02/20/2023
Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older
Vaccine. 2023 Jan 09 (website)
01/09/2023
Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020
Vaccine. 2022 Nov 08 (website)
11/08/2022
Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years
Vaccine. 2022 Oct 26 (website)
10/26/2022
A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study
JMIR. 2022 Sep14 (website)
09/14/2022
Active Surveillance of Vaccine Safety: Intermediate/Advanced Topics in Vaccine Epidemiology (ICPE 2022), Hui Lee Wong, PhD
08/25/2022
Active, surveillance, vaccine
Assessment of performance characteristics of COVID-19 ICD-10-CM diagnosis code U07.1 using SARS-CoV-2 nucleic acid amplification test results
PLoS One. 2022 Aug 18 (website)
08/18/2022
Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19
PLoS One. 2022 Aug 18 (website)
08/18/2022
Setting The World on FHIR
HL7 Case Study. 2022 Jul (website)
07/2022
Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases
Lancet. 2022 Jun 11 (pdf)
- Lancet. Supplementary. 2022 Jun 11 (pdf)
- Lancet. Commentary. 2022 Jun 11 (pdf)
- FDA BEST Lancet 2022-All Files (zip)
Show more +
This publication also includes a supplementary appendix and commentary.
06/11/2022
Risk, myocarditis, pericarditis, COVID-19 mRNA vaccinations, administrative claims
The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing
Frontiers. 2021 Dec 22 (website)
12/22/2021
Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–2018
Vaccine. 2021 Oct 01 (pdf)
10/01/2021
Vaccine exposure, pregnancy, Insured women
Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database
Drug Saf. 2021 Sep 30 (website)
09/30/2021
Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database
PLoS One. 2021 Jul 01 (pdf)
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253580
07/01/2021
Acute myocardial infarction ICD-10, administrative claims, algorithm
CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System
2021 FDA Science Forum. 2021 May 26 (website)
Presentation begins at the 2:12:00 mark
05/26/2021
Development of an Application That Semi-Automates Clinician Verification and Reporting of Transfusion Allergic Reaction Cases
AABB. 2020 Oct 3-5 (website)
10/03-05/2020
Development of a SMART-on-FHIR-enabled Semi-Automated Adverse Event Validation and Reporting Application
FHIR DevDays. 2020 June (website)
06/2020
An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics
01/29/2020
DIA PV and Risk Management Strategies Conference
Biologics Effectiveness and Safety (BEST) Initiative: Sentinel Public Meeting 2019
04/03/2019
Sentinel Public Meeting 2019
Biologics Effectiveness and Safety (BEST) Initiative: First Year
10/12/2018
OHDSI Symposium 2018