Table 1.

Proposed modification of the 2010 World Allergy Organization grading system

Grading system for SARs
Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
			Anaphylaxis
Symptom(s)/sign(s) from 1 organ system present Cutaneous • Urticaria and/or erythema-warmth and/or pruritus, other than localized at the injection site And/or • Tingling, or itching of the lips* or • Angioedema (not laryngeal)* Or Upper respiratory • Nasal symptoms (eg, sneezing, rhinorrhea, nasal pruritus, and/or nasal congestion) And/or • Throat-clearing (itchy throat)* And/or • Cough not related to bronchospasm Or Conjunctival • Erythema, pruritus, or tearing Or Other • Nausea • Metallic taste	Symptom(s)/sign(s) from ≥2 organ symptoms listed in grade 1	Lower airway • Mild bronchospasm, eg, cough, wheezing, shortness of breath which responds to treatment And/or Gastrointestinal • Abdominal cramps* and/or vomiting/diarrhea Other • Uterine cramps • Any symptom(s)/sign(s) from grade 1 would be included	Lower airway • Severe bronchospasm, eg, not responding or worsening in spite of treatment And/or Upper airway • Laryngeal edema with stridor • Any symptom(s)/sign(s) from grades 1 or 3 would be included	Lower or upper airway • Respiratory failure And/or Cardiovascular • Collapse/hypotension^ And/or  Loss of consciousness (vasovagal excluded) • Any symptom(s)/sign(s) from grades 1, 3, or 4 would be included

Notes: The final grade of the reaction is not determined until the event is over, regardless of the medication administered to treat the reaction. The final report should include the first symptom(s)/sign(s) and the time of onset after the causative agent exposure and a suffix reflecting if and when epinephrine was or was not administered: a, ≤5 min; b, >5 min to ≤10 min; c, >10 to ≤20 min; d, >20 min; z, epinephrine not administered. Final report: Grade 1-5; a-d, or z; First symptom(s)/sign(s); Time of onset of first symptom(s)/signs(s). Case example. Within 10 min of receiving an AIT injection, a patient develops generalized urticaria followed by a tickling sensation in the posterior pharynx. Intramuscular epinephrine is administered within 5 min of symptoms(s)/sign(s) resulting in complete resolution of the reaction. The final report would be: Grade 2; a; Urticaria; 10 min.

^*Application-site reactions would be considered local reactions. Oral mucosa symptoms, such as pruritus, after SLIT administration, or warmth and/or pruritus at a subcutaneous immunotherapy injection site would be considered a local reaction. However, tingling or itching of the lips or mouth could be interpreted as a SAR if the known allergen, eg, peanut, is inadvertently placed into the mouth or ingested in a subject with a history of a peanut-induced SAR. Gastrointestinal tract reactions after SLIT or OIT would also be considered local reactions, unless they occur with other systemic manifestations. SLIT or OIT reactions associated with gastrointestinal tract and other systemic manifestations would be classified as SARs. SLIT local reactions would be classified according to the WAO grading system for SLIT local reactions.³³ A fatal reaction would not be classified in this grading system but rather reported as a serious adverse event.

^{^}Hypotension is defined per the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Expert Panel criteria³⁴: “Reduced blood pressure after exposure to known allergen for that subject (minutes to several hours). A) Infants and children: low systolic blood pressure (age-specific) or greater than 30% decrease in systolic blood pressure. Low systolic blood pressure for children is defined as follows: 1 mo to 1 y: <70 mm Hg, 1–10 y: <70 mm Hg + [2 × age], 11–17 y: <90 mm Hg. B) Adults: systolic blood pressure of less than 90 mm Hg or greater than 30% decrease from that person’s baseline. Reprinted from The Journal of Allergy and Clinical Immunology: In Practice, Volume 5(1), Cox LS, Sanchez-Borges M, Lockey RF, World allergy organization systemic allergic reaction grading system: is a modification needed? Pages 58–62.e55, Copyright 2017, with permission from Elsevier.⁴

Abbreviations: AIT, allergen immunotherapy; OIT, oral immunotherapy; SLIT, sublingual immunotherapy; WAO, World Allergy Organization.