TABLE 4.

Frequencies of the most common vaccine-related adverse eventsa

Adverse eventNo. (%) of subjects
V710 5 μg (n = 31)V710 30 μg (n = 28)V710 90 μg (n = 34)Placebo (n = 31)
Systemicb
    Fatigue4 (13)2 (7)3 (9)3 (10)
    Headache6 (19)5 (18)3 (9)4 (13)
    Myalgia3 (10)2 (7)2 (6)5 (16)
    Nausea2 (7)3 (11)3 (9)1 (3)
Injection site
    Bruising0 (0)1 (4)0 (0)1 (3)
    Erythema3 (1)0 (0)0 (0)1 (3)
    Pain14 (45)16 (57)16 (47)7 (23)
    Swelling2 (7)3 (11)1 (3)3 (10)
  • a All vaccinated patients were included in the safety assessment. Injection-site reactions and body temperature were monitored for 5 days following vaccination. Data for systemic adverse events were collected for 14 days following vaccination.

  • b Includes all systemic adverse events occurring in ≥10% of any treatment group. Subjects were asked to record adverse events on a standardized vaccination report card, which explicitly asked about nausea, headache, myalgia, and fatigue.