Table 2.

Summary of treatment-related adverse events

Adverse eventAll gradesGrade 3 or 4
Patients, n%Patients, n%
Local vaccine site reactions
 Erythema/induration2010000
 Pruritus2010000
 Pain/soreness/tenderness178500
 Local rash at/near vaccine site73515
 Blister formation52500
 Hyperpigmentation42000
 Ecchymosis (bruising)31500
 Local edema21000
 Vaccine site flare21000
 Groin tightness1500
Systemic toxicities
 Fatigue840
 Urticaria735210
 Pruritus (distant from vaccine site)63015
 Fever525
 Flu-like symptoms/myalgia420
 Lymphadenopathy420
 Abdominal pain31515
 Rash (distant from vaccine site)31515
 Achiness/malaise315
 Chills315
 Dizziness210
 Anorexia15
 Erythema (distant from vaccine site)15
 Headache15
 Nausea15
 Arm pain15
 Cancer site pain15
 Leg tenderness15

NOTE: Data are given as any incident per patient, for a maximum of 20 counts per event.