Consultation Document for Case Definitions Adverse Events of Special Interest and Adverse Events Following Immunization during COVID-19 Vaccine Introduction 0 Consultation Document for Case Definitions Adverse Events of Special Interest and Adverse Events Following Immunization during COVID-19 Vaccine Introduction Washington, D.C., 2021 Consultation Document for Case Definitions: Adverse Events of Special Interest and Adverse Events Following Immunization during COVID-19 Vaccine Introduction PAHO/HSS/MT/COVID-19/21-0006 © Pan American Health Organization, 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO license (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 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The opinions expressed in this document in no way represent the official views of the European Union. iii CONTENTS ABREVIATIONS AND ACRONYMS .........................................................................v INTRODUCTION ............................................................................................... 1 PART A: Adverse events of special interest (AESI).................................................. 3 1. Generalized convulsive .............................................................................. 3 2. Guillain-Barré syndrome (GBS) .................................................................... 3 3. Acute disseminated encephalomyelitis (ADEM) ............................................. 4 4. Anosmia, ageusia ...................................................................................... 5 5. Meningoencephalitis ................................................................................. 5 6. Aseptic meningitis ..................................................................................... 6 7. Facial nerve palsy ...................................................................................... 6 8. Narcolepsy ............................................................................................... 7 9. Enhanced COVID-19 disease following immunization...................................... 7 10. Multisystem inflammatory syndrome in children (MIS-C) .............................. 8 11. Anaphylaxis ............................................................................................ 8 12. Acute aseptic arthritis (AAA) ..................................................................... 9 13. Acute respiratory distress syndrome (ARDS) ...............................................10 14. Acute cardiac injury ................................................................................10 15. Coagulation disorder...............................................................................11 16. Thrombocytopenia (TP) ...........................................................................12 17. Acute kidney injury (AKI) .........................................................................12 18. Chilblain-like lesions ...............................................................................12 19. Single organ cutaneous vasculitis (SOCV) ...................................................13 20. Erythema multiforme (EM) ......................................................................13 21. Acute liver injury (ALI) .............................................................................14 22. Subacute thyroiditis (SAT)........................................................................14 23. Rhabdomyolysis .....................................................................................14 24. Acute pancreatitis (AP)............................................................................15 PART B: Adverse events following immunization (AEFI).........................................16 25. Fever following immunization ..................................................................16 26. Fatigue .................................................................................................16 27. Joint pain ..............................................................................................17 28. Diarrhea................................................................................................17 29. Chills ....................................................................................................18 30. Headache ..............................................................................................18 31. Injection site reactions ............................................................................19 iii 32. Malaise .................................................................................................19 33. Muscle pain (myalgia) .............................................................................20 34. Nausea/vomiting ....................................................................................20 35. Neutropenia ..........................................................................................20 36. Redness ................................................................................................21 37. Swelling ................................................................................................21 38. Lymphadenopathy..................................................................................22 39. Allergic reactions (hypersensitivity) ...........................................................22 40. Death ...................................................................................................22 PART C: Expanded case definitions ....................................................................23 According to Brighton Collaboration case definition of generalized convulsive seizure as an adverse event following immunization .........................................23 REFERENCES...................................................................................................54 ABREVIATIONS AND ACRONYMS AAA Acute aseptic arthritis AASM American Academy of Sleep Medicine ABI Ankle-brachial index ACCESS Vaccine COVID-19 monitoring readiness ACS Acute coronary syndrome ADEM Acute disseminated encephalomyelitis ADQI Acute Dialysis Quality Initiative AEFI Adverse events following immunization AESI Adverse events of special interest AF Atrial fibrillation AHF Acute heart failure AHEI Acute haemorrhagic edema of infancy AKI Acute kidney injury AKIN Acute Kidney Injury Network ALF Acute liver failure ALI Acute liver injury ALP Alkaline phosphatase ALT Alanine transaminase AMI Acute myocardial infarction AP Acute pancreatitis ARDS Acute respiratory distress syndrome BC Brighton Collaboration BNP Brain natriuretic peptide BSA Body surface area CCP Anticitrullinated peptides antibodies CDC Centers for Disease Control and Prevention CEPI Coalition for Epidemic Preparedness Innovations CFR Coronary flow reserve CFS Chronic fatigue syndrome CMD Coronary microvascular dysfunction CMR Cardiac magnetic resonance COVID-19 Coronavirus disease 2019 CPAP Continuous positive airway pressure CRS Chronic rhinosinusitis CSF Cerebrospinal fluid CSVV Cutaneous small vessel vasculitis CV Cutaneous vasculitis DILI Drug-induced liver injury DVT Deep vein thrombosis DWI Diffusion weighted ECG Electrocardiogram EDF Event definition form EM Erythema multiforme ESKD End-stage kidney disease FIO2 Fraction of inspired oxygen FFR Fractional flow reserve FLAIR Fluid-attenuated inversion recovery GBS Guillain-Barré syndrome GFR Glomerular filtration rate GGT Gamma-glutamyl transferase HE Hepatic encephalopathy HF Heart failure HFmrEF Heart failure with mid-range ejection fraction HFpEF Heart failure with preserved ejection fraction HFrEF Heart failure with reduced ejection fraction IASL International Association for the Study of the Liver IASP International Association for the Study of Pain IgE immunoglobulin E IMR Index of coronary muscular resistance INR International normalized ratio KD Kawasaki disease KDIGO Kidney Disease-Improving Global Outcomes LUMP Solid formation LV Left ventricular LVEF Left ventricular ejection fraction MAS Macrophage activation syndrome MDRD Modification of diet in renal disease MI Myocardial infarction MIS-A Multisystem inflammatory syndrome in adult MIS-C Multisystem inflammatory syndrome in children MRI Magnetic resonance imaging MSLT Mean sleep latency PAO2 Partial pressure of arterial oxygen PAC Premature atrial contractions PAD Peripheral artery disease PCR Polymerase chain reaction PE Pulmonary Thromboembolism PEEP Positive end-expiratory pressure PMN Polymorphonuclear leukocyte POAD Peripheral occlusive artery disease PSVT