Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

logo

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

_____

Anne R. Bass, Kathleen Stratton,
Ogan K. Kumova, and Dara Rosenberg, Editors

Committee to Review Relevant Literature
Regarding Adverse Events Associated with Vaccines

Board on Population Health and
Public Health Practice

Health and Medicine Division

Consensus Study Report

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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This activity was supported by a contract between the National Academy of Sciences and Health Resources and Services Administration, which includes funds from the Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Evidence review of the adverse effects of COVID-19 vaccination and intramuscular vaccine administration. Washington, DC: The National Academies Press. https://doi.org/10.17226/27746.

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

COMMITTEE TO REVIEW RELEVANT LITERATURE REGARDING ADVERSE EVENTS ASSOCIATED WITH VACCINES

GEORGE J. ISHAM (Chair), Senior Fellow, HealthPartners Institute

ANNE R. BASS (Vice Chair), Professor of Clinical Medicine, Department of Medicine, Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine

ALICIA CHRISTY, Professor of Obstetrics and Gynecology, Uniformed Services University; Adjunct Professor, Howard University School of Medicine

DELISA FAIRWEATHER, Professor of Medicine, Director of Translational Research, Department of Cardiovascular Medicine; Codirector of Research for the Ehlers-Danlos Syndrome Clinic, Department of General Internal Medicine, Mayo Clinic (Jacksonville, FL)

JAMES S. FLOYD, Codirector of the Cardiovascular Health Research Unit, Associate Professor of Medicine, Adjunct Professor of Epidemiology, University of Washington

ERIC J. HEGEDUS, Professor and Chair, Department of Rehabilitation Science, Tufts University School of Medicine

CHANDY C. JOHN, Ryan White Professor of Pediatrics, Professor of Medicine, Professor of Microbiology and Immunology, Director of the Ryan White Center for Pediatric Infectious Diseases and Global Health, Indiana University School of Medicine

JOHN EDWARD KUHN, Schermerhorn Professor of Orthopaedic Surgery, Chief of Shoulder Surgery, Department of Orthopaedic Surgery, Vanderbilt University Medical Center

EVAN MAYO-WILSON, Associate Professor, Department of Epidemiology, University of North Carolina Gillings School of Global Public Health

THOMAS LEE ORTEL, Chief, Division of Hematology, Department of Medicine; Professor of Medicine and Pathology, Duke University School of Medicine

NICHOLAS S. REED, Assistant Professor, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health; Assistant Professor, Department of Otolaryngology, Division of Otology/Audiology, Johns Hopkins University School of Medicine

ANDY S. STERGACHIS, Professor and Associate Dean of Pharmacy, School of Pharmacy; Professor of Global Health, School of Public Health, University of Washington

MICHEL TOLEDANO, Assistant Professor of Neurology, Department of Neurology, Mayo Clinic (Rochester, MN)

ROBERT B. WALLACE, Irene Ensmenger Stecher Professor Emeritus of Epidemiology and Internal Medicine, University of Iowa

OUSSENY ZERBO, Research Scientist II, Vaccine Study Center, Division of Research, Kaiser Permanente Northern California

National Academy of Medicine Fellow

INMACULADA HERNANDEZ, Professor, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California

Health and Medicine Division Staff

KATHLEEN STRATTON, Study Director

OGAN K. KUMOVA, Program Officer (since February 2023)

DARA ROSENBERG, Associate Program Officer

NERISSA HART, Senior Program Assistant (through May 2023)

OLIVIA LOIBNER, Senior Program Assistant (since June 2023)

MISRAK DABI, Finance Business Partner

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

REBECCA MORGAN, Senior Research Librarian

ANNE MARIE HOUPPERT, Senior Research Librarian

ROSE MARIE MARTINEZ, Senior Board Director, Board on Population Health and Public Health Practice

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

DOUGLAS B. CINES, Director, Coagulation Laboratory; Director, Office of Faculty Development, Pathology and Laboratory Medicine; Professor of Pathology and Laboratory Medicine (Hematology-Oncology), University of Pennsylvania School of Medicine

BETTY DIAMOND, Director, Institute of Molecular Medicine, The Feinstein Institutes for Medical Research North Shore-LIJ Health System, Northwell Health

KATHRYN EDWARDS, Professor of Pediatrics; Sarah H. Sell and Cornelius Vanderbilt Chair, Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center

MARIE GRIFFIN, Professor Emerita, Vanderbilt University School of Medicine

AKIKO IWASAKI, Howard Hughes Medical Institute Investigator; Director, Center for Infection and Immunity; Sterling Professor of Immunobiology and Molecular, Cellular, and Developmental Biology, Yale University

EMILY JUNGHEIM, Chief of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology, Northwestern University

GRACE M. LEE, Professor of Pediatrics, Stanford Medicine Children’s Health

TIANJING LI, Associate Professor, University of Colorado Anschutz Medical Campus

JENNIFER S. LIN, Distinguished Investigator, Kaiser Permanente Center for Health Research

CLAUDIA LUCCHINETTI, Dean, Dell Medical School; Senior Vice President for Medical Affairs, University of Texas at Austin

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

H. CODY MEISSNER, Professor of Pediatrics and Medicine, Geisel School of Medicine at Dartmouth; Senior Vaccine and Biologics Development Analyst, Biomedical Advanced Research and Development Authority; Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services

BRIAN OLSHANSKY, Emeritus Professor of Internal Medicine–Cardiovascular Medicine, Carver College of Medicine, University of Iowa, University of Iowa Hospitals and Clinics

JAMES SEGARS, Director, Division of Reproductive Sciences and Women’s Health Research, Johns Hopkins University School of Medicine

UMASUTHAN SRIKUMARAN, Assistant Professor, Orthopaedic Surgery, Johns Hopkins University

GRETA C. STAMPER, Audiology Division Chair, Audiology Externship Program Director, Consultant in Otorhinolaryngology, Mayo Clinic

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of this report was overseen by coordinator DAVID SAVITZ, Professor of Epidemiology, Brown University, and monitor WALTER FRONTERA, Professor of Physical Medicine, Rehabilitation, and Sports Medicine, University of Puerto Rico School of Medicine. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

Acknowledgments

The Committee to Review Relevant Literature Regarding Adverse Events Associated with Vaccines and the committee staff would like to thank many individuals for their contributions throughout all phases of the study: Misrak Dabi (Finance Business Partner), Crysti Park (Program Coordinator), Lori Brenig (Editorial Projects Coordinator), Taryn Young (Report Review Associate), Leslie Sim (Senior Report Review Officer), Benjamin Hubbert (Communications Specialist), Amber McLaughlin (Director of Communications), Tasha Bigelow (Copy Editor), Rebecca Morgan (Senior Research Librarian), and Anne Marie Houppert (Senior Research Librarian).

The committee acknowledges and thanks the members of the public who provided valuable insight to the committee via email correspondence and in public comments.

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

9-1 Conclusions for Female Infertility

10-1 Conclusions for Shoulder Injuries

11-1 Conclusions Regarding BNT162b2

11-2 Conclusions Regarding mRNA-1273

11-3 Conclusions Regarding Ad26.COV2.S

11-4 Conclusions Regarding NVX-CoV2373

11-5 Conclusions Regarding Shoulder Injuries

11-6 Conclusions for Which the Evidence Establishes a Causal Relationship

11-7 Conclusions for Which the Evidence Favors Acceptance of a Causal Relationship

11-8 Conclusions for Which the Evidence Favors Rejection of a Causal Relationship

FIGURES

2-1 COVID-19 vaccines contributing to this report and their mechanism of action

2-2 Immune responses to intramuscular administration of SARS-CoV-2 mRNA vaccines

3-1 Overview of the pathogenesis and therapeutic targets of the two major Guillain-Barré syndrome subtypes

3-2 Postulated mechanisms of orthostatic intolerance and tachycardia in postural orthostatic tachycardia syndrome

10-1 Illustration of intramuscular injection techniques

TABLES

S-1 Causal Conclusions Regarding COVID-19 Vaccines

S-2 Conclusions Regarding Shoulder Injuries After Any Vaccination

1-1 COVID-19 Vaccines Used in the United States

1-2 COVID-19 Vaccine Food and Drug Administration Emergency Use Authorization Dates, Adults and Children

2-1 Immune Responses to U.S. COVID-19 Vaccines

2-2 Vaccine-Mediated Reactions and Their Mechanisms

2-3 Most Commonly Used Adjuvants in Vaccines

3-1 Epidemiological Studies in the Guillain-Barré Syndrome Evidence Review

3-2 Pharmacovigilance Studies in the Guillain-Barré Syndrome Evidence Review

3-3 Epidemiological Study in the Chronic Inflammatory Demyelinating Polyneuropathy Evidence Review

3-4 Epidemiological Studies in the Bell’s Palsy Evidence Review

3-5 Epidemiological Studies in the Transverse Myelitis Evidence Review

3-6 Epidemiological Study in the Postural Orthostatic Tachycardia Syndrome Evidence Review

4-1 Epidemiological Studies in the Sensorineural Hearing Loss Evidence Review

4-2 Epidemiological Studies in the Tinnitus Evidence Review

5-1 Epidemiological Studies in the Thrombosis with Thrombocytopenia Evidence Review

5-2 Epidemiological Studies in the Immune Thrombocytopenic Purpura Evidence Review

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

6-1 Epidemiological Studies in the Vascular Conditions Evidence Review

6-2 Epidemiological Studies in the BNT162b2–Myocardial Infarction Evidence Review

6-3 Epidemiological Studies in the mRNA-1273–Myocardial Infarction Evidence Review

6-4 Epidemiological Study in the Ad26.COV2.S–Myocardial Infarction Evidence Review

6-5 Epidemiological Studies in the BNT162b2–Ischemic Stroke Evidence Review

6-6 Epidemiological Study in the mRNA-1273–Ischemic Stroke Evidence Review

6-7 Epidemiological Study in the Ad26.COV2.S–Ischemic Stroke Evidence Review

6-8 Epidemiological Studies in the BNT162b2–Hemorrhagic Stroke Evidence Review

6-9 Epidemiological Study in the mRNA-1273–Hemorrhagic Stroke Evidence Review

6-10 Epidemiological Study in the Ad26.COV2.S–Hemorrhagic Stroke Evidence Review

6-11 Epidemiological Studies in the BNT162b2–Deep Vein Thrombosis Evidence Review

6-12 Epidemiological Studies in the BNT162b2–Pulmonary Embolism Evidence Review

6-13 Epidemiological Studies in the mRNA–1273–Pulmonary Embolism Evidence Review

6-14 Epidemiological Study in the Ad26.COV2.S–Pulmonary Embolism Evidence Review

6-15 Epidemiological Studies in the BNT162b2–Venous Thromboembolism Evidence Review

7-1 Findings from Canada’s Strategy for Patient-Oriented Research

7-2 Selected Epidemiological Studies of Risk of Myocarditis Associated with BNT162b2

7-3 Selected Epidemiological Studies of Risk of Pericarditis Associated with BNT162b2

7-4 Reports to the Vaccine Adverse Event Reporting System After mRNA-Based COVID-19 Vaccination That Met the Centers for Disease Control and Prevention’s Case Definition for Myocarditis Within a 7-Day Risk Interval per Million Doses of Vaccine Administered

7-5 Selected Epidemiological Studies of Risk of Myocarditis Associated with mRNA-1273

7-6 Selected Epidemiological Studies of Risk of Pericarditis Associated with mRNA-1273

8-1 Epidemiological Study in the Sudden Death Evidence Review

9-1 Clinical and Epidemiological Studies in the Female Infertility Evidence Review

10-1 Case Reports Regarding Subacromial/Subdeltoid Bursitis After Vaccination

10-2 Case Reports of Acute Rotator Cuff or Acute Biceps Tendinopathy After Vaccination

10-3 Case Reports of Adhesive Capsulitis After Vaccination

10-4 Case Reports of Septic Arthritis After Vaccination

10-5 Case Reports of Bone Injury After Vaccination

10-6 Case Reports of Axillary or Radial Nerve Injury After Vaccination

10-7 Case Reports of Parsonage-Turner Syndrome After Vaccination

10-8 Budapest Criteria to Diagnose Complex Regional Pain Syndrome

10-9 Case Reports of Complex Regional Pain Syndrome After Vaccination

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

Preface

In the 4 years since the first case of COVID-19 was recognized and after a pandemic was declared by the World Health Organization 3 months later in March 2020, an estimated 3.5 million died from SARS-CoV-2 infection. Millions more became ill, and some have suffered long-term effects (“long COVID”) that are not yet understood fully. Aside from its health impact, the pandemic has caused marked social, economic, and political upheaval. We doubt any have had lives unchanged by COVID-19.

The response to the pandemic has been extraordinary. By spring 2021, only 1 year after the pandemic declaration, vaccines authorized by the Food and Drug Administration for emergency use were being administered across the United States, indeed, around the world. It is estimated that more than 14 million lives were saved in the year after vaccines became available, with one death avoided for every 124 full vaccination courses. Lives were also saved by other public health interventions and often-heroic efforts of health care workers and health care systems.

In the 3 years since vaccines against SARS-CoV-2 came into use, their safety and efficacy have been established. Booster vaccinations and vaccines targeting new SARS-CoV-2 strains have been introduced and are now administered routinely alongside other vaccinations such as for influenza. While local, nonserious side effects, such as malaise or sore arm, are seen as with any vaccine, in rare instances, serious adverse events thought to be linked to SARS-CoV-2 vaccination have been noted.

The National Academies of Sciences, Engineering, and Medicine (the National Academies) have long tackled challenging questions about vaccine safety, beginning with an assessment of the oral polio vaccine in 1977. When Congress enacted the National Childhood Vaccine Injury Act in 1986, it charged the Institute of Medicine (IOM) with reviewing the literature regarding adverse events associated with vaccines covered by the program. The IOM1 has addressed questions about the safety of routinely administered vaccines 11 times since then. Following in this tradition, the National Academies tasked this consensus committee to assess the scientific evidence dispassionately regarding a list of harms potentially associated with vaccination against SARS-CoV-2, as well as an important potential harm associated with the administration of any vaccine, shoulder injury.

Thanks to the extraordinary efforts of investigators around the world who rapidly pivoted their research efforts to focus on this new virus (including its treatment and prevention), we now have a large body of evidence to consider. However, despite that large body of evidence, our consensus committee found that in many, if not most,

___________________

1 As of March 2016, the Health and Medicine Division continues the consensus studies and convening activities previously carried out by the Institute of Medicine (IOM).

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

cases, the evidence was insufficient to accept or reject causality for a particular potential harm from a specific COVID-19 vaccine. In other cases, however, the committee considered the evidence to be sufficient to “favor rejection” of, to “favor acceptance” of, or to “establish causality.”

Limitations inherent in applying population-level average effects to draw conclusions about causes of specific events in individual subjects exist. For this reason, there is asymmetry in the committee’s conclusions, with options to conclude that the evidence “establishes a causal relationship,” “favors acceptance of causal relationship,” or “favors rejection of a causal relationship,” but not one to “establish rejection of a causal relationship.”

For every potential harm assessed, the committee evaluated the totality of evidence and did not apply what could be seen as arbitrary rules or thresholds regarding the number or types of studies required to draw conclusions. For the evaluation of select postulated vaccine harms, some study types were simply not available or were uninformative. For some cases, there was strong mechanistic as well as epidemiologic evidence supporting a causal relationship (e.g., thrombosis with thrombocytopenia syndrome), while, in others, the evidence was drawn largely from case reports.

COVID-19 has, understandably, dominated headlines over the past 3 years, yet routine vaccinations, such as for seasonal influenza, are still given. The harms our committee was tasked to review were those for which the Health Resources and Services Administration had claims for compensation. Perhaps surprisingly, only a minority of these claims related to SARS-CoV-2 vaccination. In fact, over 60 percent of claims focused on shoulder injury associated with intramuscular vaccine administration.

The term “SIRVA” (shoulder injury related to vaccine administration) has been introduced into the literature in recent years and was included in the committee’s Statement of Task. However, the term “SIRVA” encompasses many disparate shoulder conditions, and due to its lack of precision, the committee decided to dispense with this terminology. Instead, the committee addressed potential causal relationships between vaccine administration and specific shoulder-related medical diagnoses (e.g., subacromial bursitis, radial nerve injury).

This report does not address benefits of vaccination against SARS-CoV-2 or other pathogens, and readers will hopefully view causality findings in that broader context. Even when evidence of causality was established for some harms, the frequency of these harms was low. However, this report explicitly does not attempt to define point estimates for levels of risk.

Many talented, knowledgeable individuals volunteered hours of their time to analyze and report the evidence. Initially strangers, the members of this committee worked through difficult methodological questions together, at times engaging in spirited debate. In the process, we learned from one another, became a team, and became friends. Equally important, members of that team were the committee staff—Dara Rosenberg, Ogan Kumova, and Olivia Loibner, led by the incredibly wise and knowledgeable Kathleen Stratton and Rose Marie Martinez. The staff worked tirelessly every step of the way, providing indispensable support and guidance, and contributing greatly to the report itself.

This is not the first HMD/National Academies report regarding vaccine safety. Nor will it be the last. We anticipate new vaccines and expect that ongoing and future scientific research may challenge the findings reported here. This report necessarily reflects a snapshot in time, albeit a momentous one, and represents our best effort to report the truth.

George J. Isham, Chair

Anne R. Bass, Vice Chair

Committee to Review Relevant Literature Regarding

Adverse Events Associated with Vaccines

Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

Acronyms and Abbreviations

AAOS American Academy of Orthopaedic Surgeons
ACE2 angiotensin-converting enzyme 2
ADE antibody dependent enhancement
ADEM acute disseminated encephalomyelitis
AFC antral follicle count
AIDP acute inflammatory demyelinating polyneuropathy
AMAN acute motor axonal neuropathy
AMH anti-Müllerian hormone
AV adenovirus vector
BP Bell’s palsy
bpm beats per minute
CAR coxsackie and adenoviral receptor
CDC Centers for Disease Control and Prevention
CGRP calcitonin gene–related peptide
CI confidence interval
CICP Countermeasures Injury Compensation Program
CIDP chronic inflammatory demyelinating polyneuropathy
CLS capillary leak syndrome
CPRD Clinical Practice Research Datalink
CRPS complex regional pain syndrome
CSF cerebrospinal fluid
CT computed tomography
CVST cerebral venous sinus thrombosis
DCM dilated cardiomyopathy
DNA deoxyribonucleic acid
DTaP diphtheria, tetanus, and acellular pertussis vaccine
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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
DVT deep vein thrombosis
EMG electromyogram
EMR electronic medical record
EUA Emergency Use Authorization
EV extracellular vesicle
FDA Food and Drug Administration
FR fecundity rate
FSH follicle-stimulating hormone
GBS Guillain-Barré syndrome
GC germinal center
HIT heparin-induced thrombocytopenia
HLA human leukocyte antigen
HPV human papillomavirus
HR hazard ratio
HRSA Health Resources and Services Administration
HS hemorrhagic stroke
HSV herpes simplex virus
ICD International Classification of Diseases
ICHD International Classification of Headache Disorders
IFN interferon
Ig immunoglobulin
IL interleukin
IOM Institute of Medicine
IQR interquartile range
IR incidence rate
IRR incidence rate ratio
ITP immune thrombocytopenic purpura
IV intravenous
LH luteinizing hormone
LLPC long-lived plasma cell
LNP lipid nanoparticle
MI myocardial infarction
MRI magnetic resonance imaging
mRNA messenger ribonucleic acid
MS multiple sclerosis
NCS nerve conduction study
NCVIA National Childhood Vaccine Injury Act
NIH National Institutes of Health
NR not reported
O:E observed-to-expected ratio
OHCA out-of-hospital cardiac arrest
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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
OPV oral polio vaccine
OR odds ratio
PE pulmonary embolism
PF4 platelet factor 4
POTS postural orthostatic tachycardia syndrome
PPV positive predictive value
PTS Parsonage-Turner syndrome
RBD receptor-binding domain
RCT randomized controlled trial
RI relative incidence
RNA ribonucleic acid
RR relative risk or risk ratio
RSV respiratory syncytial virus
SARS-CoV-2 severe acute respiratory syndrome coronavirus-2
SCCS self-controlled case series
SHBG sex hormone binding globulin
SIDIAP Information System for the Development of Research in Primary Care
SIR standardized incidence ratio
SIRVA shoulder injury related to vaccine administration
SPOR Strategy for Patient-Oriented Research
SSNHL sudden sensorineural hearing loss
SSP supraspinatus
SUD sudden unexpected death
Tfh T follicular helper
TLR Toll-like receptor
TM transverse myelitis
TNF tumor necrosis factor
TTH tension-type headache
TTS thrombosis with thrombocytopenia syndrome
UI uncertainty interval
VAED vaccine-associated enhanced disease
VAERS Vaccine Adverse Event Reporting System
VICP Vaccine Injury Compensation Program
VITT vaccine-induced immune thrombotic thrombocytopenia
VSD Vaccine Safety Datalink
VTE venous thromboembolism
WHO World Health Organization
YLD years lived with disability
YLL years of life lost
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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.

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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
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Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R7
Page viii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R8
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R9
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R10
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R11
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R12
Page xiii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R13
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R14
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R15
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R16
Page xvii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R17
Page xviii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R18
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R19
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R20
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R21
Page xxii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R22
Page xxiii Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R23
Page xxiv Cite
Suggested Citation: "Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. Washington, DC: The National Academies Press. doi: 10.17226/27746.
Page R24
Next Chapter: Summary
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