Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration

Vaccines are a public health success story, as they have prevented or lessened the effects of many infectious diseases. To address concerns around potential vaccine injuries, the Health Resources and Services Administration (HRSA) administers the Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP), which provide compensation to those who assert that they were injured by routine vaccines or medical countermeasures, respectively. The National Academies of Sciences, Engineering, and Medicine have contributed to the scientific basis for VICP compensation decisions for decades.

HRSA asked the National Academies to convene an expert committee to review the epidemiological, clinical, and biological evidence about the relationship between COVID-19 vaccines and specific adverse events, as well as intramuscular administration of vaccines and shoulder injuries. This report outlines the committee findings and conclusions.

Table of Contents

Front Matter Summary 1 Introduction 2 Immunologic Response to COVID-19 Vaccines 3 Neurologic Conditions and COVID-19 Vaccines 4 Sensorineural Hearing Loss, Tinnitus, and COVID-19 Vaccines 5 Thrombosis with Thrombocytopenia Syndrome, Immune Thrombocytopenic Purpura, Capillary Leak Syndrome, and COVID-19 Vaccines 6 Vascular Conditions and COVID-19 Vaccines: Myocardial Infarction, Stroke, Pulmonary Embolism, Deep Vein Thrombosis, and Venous Thromboembolism 7 Myocarditis, Pericarditis, and COVID-19 Vaccines 8 Sudden Death and COVID-19 Vaccines 9 Female Infertility and COVID-19 Vaccines 10 Shoulder Injuries and Vaccines 11 Crosscutting Remarks Appendix A: Committee Member and Staff Biographies Appendix B: Public Meeting Agenda