| Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States | 2025/11/24 |
| Safety monitoring of health outcomes following influenza vaccination during the 2023-2024 season among U.S. Commercially-insured individuals aged 6 months through 64 years: Self-controlled case series analyses | 2025/09/17 |
| Safety Monitoring of Bivalent COVID-19 mRNA Vaccines Among Recipients 6 Months and Older in the United States | 2025/05/06 |
| Effectiveness over time of a primary series of the original monovalent COVID-19 vaccines in adults in the United States | 2025/05/06 |
| Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Medicare beneficiaries aged 65 years and older | 2025/04/19 |
| Differences in influenza testing and treatment in micropolitan versus metropolitan areas in the U.S. using medicare claims data from 2010 to 2016 | 2025/01/23 |
| Lessons Learned From Characterizing Long COVID Among US Medicare Beneficiaries | 2025/01/22 |
| A Computable Phenotype Algorithm for Postvaccination Myocarditis/Pericarditis Detection Using Real-World Data: Validation Study | 2024/11/25 |
| Relative Effectiveness and Waning of a Third Dose of mRNA COVID-19 Vaccine in Medicare Beneficiaries Aged 65 Years and Older during the BA.1/BA.2 Omicron Period | 2024/10/15 |
| Stroke After Influenza Vaccines in Older Adults in the US, 2016 to 2019 | 2024/07/22 |
| Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study | 2024/07/15 |
| Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform | 2024/07/07 |
| Assessment of potential adverse events following the 2022–2023 seasonal influenza vaccines among U.S. adults aged 65 years and older | 2024/05/03 |
| Patterns of red blood cell utilization: Harnessing electronic health records data from the Information Standard for Blood and Transplant (ISBT) 128 system within the Biologics Effectiveness and Safety (BEST) initiative | 2024/04/30 |
| Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study | 2024/04/26 |
| Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years | 2024/04/24 |
| Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults | 2024/03/19 |
| Real-world Effectiveness of mRNA COVID-19 Vaccines Among US Nursing Home Residents Aged ≥65 Years in the Pre-Delta and High Delta Periods | 2024/01/29 |
| CBER BEST IM Exchange Pilot - Biologics Effectiveness and Safety Innovative Methods | 2023/11/14 |
| Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure | 2023/10/14-17 |
| Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure: Pilot | 2023/09/12 |
| 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. | 2023/07/19 |
| Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination | 2023/06/23 |
| Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis | 2023/06/07 |
| Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years | 2023/05/22 |
| Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies | 2023/05/16 |
| Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis | 2023/03/03 |
| Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases | 2023/03/01 |
| Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion | 2023/02/24 |
| Immune globulin usage trends in commercially insured and Medicare populations, 2009-2019 | 2023/02/20 |
| Comparison of adverse pregnancy and birth outcomes using archival medical records before and during the first wave of the COVID-19 pandemic in Kinshasa, Democratic Republic of Congo: a facility-based, retrospective cohort study | 2023/01/16 |
| Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older | 2023/01/09 |
| Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020 | 2022/11/08 |
| Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years | 2022/10/26 |
| Detection of allergic transfusion-related adverse events from electronic medical records | 2022/10 |
| A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study | 2022/09/14 |
Active Surveillance of Vaccine Safety: Intermediate/Advanced Topics in Vaccine Epidemiology (ICPE 2022), Hui Lee Wong, PhD | 2022/08/25 |
| Assessment of performance characteristics of COVID-19 ICD-10-CM diagnosis code U07.1 using SARS-CoV-2 nucleic acid amplification test results | 2022/08/18 |
| Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19 | 2022/08/18 |
| Operational lessons learned in conducting an international study on pharmacovigilance in pregnancy in resource-constrained settings: The WHO Global Vaccine safety Multi-Country collaboration project | 2022/08 |
| Adherence to face mask use during the COVID-19 pandemic among women seeking antenatal care in Kinshasa, Democratic Republic of Congo: a facility-based cross-sectional study | 2022/07/08 |
| Setting The World on FHIR | 2022/07 |
| Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases, February-November 2020 | 2022/06/18 |
| Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases | 2022/06/11 |
| Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16-29 years | 2022/04/26 |
| Risk Factors for COVID-19 Deaths Among Elderly Nursing Home Medicare Beneficiaries in the Prevaccine Period | 2022/02/15 |
| 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 | 2021/12/22 |
| Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries | 2021/12/01 |
| Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–2018 | 2021/10/01 |
| Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database | 2021/09/30 |
| Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review | 2021/09/24 |
Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253580 | 2021/07/01 |
| U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines | 2021/06/23 |
CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System
Presentation begins at the 2:12:00 mark | 2021/05/26 |
| Natural History of Coronavirus Disease 2019: Risk Factors for Hospitalizations and Deaths Among >26 Million US Medicare Beneficiaries | 2021/03/29 |
| Development of an Application That Semi-Automates Clinician Verification and Reporting of Transfusion Allergic Reaction Cases | 2020/10/03-05 |
| Development of a SMART-on-FHIR-enabled Semi-Automated Adverse Event Validation and Reporting Application | 2020/06 |
| An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics | 2020/01/29 |
| Biologics Effectiveness and Safety (BEST) Initiative: Sentinel Public Meeting 2019 | 2019/04/03 |
| Biologics Effectiveness and Safety (BEST) Initiative: First Year | 2018/10/12 |
