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. 2012 Jan 24;205(5):703–712. doi: 10.1093/infdis/jir837

Table 2.

Solicited Injection Site and Systemic Adverse Events Reported by Participants Within 8 Days of Each Vaccination

CD4 <200 cells/mL
CD4 ≥200 cells/mL
15 μg HA
30 μg HA
15 μg HA
30 μg HA
Adverse Event 1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose
Systemic symptoms
    ≥1 symptom 14 (40%) 8 (24%) 14 (37%) 9 (27%) 24 (40%) 15 (25%) 24 (39%) 18 (30%)
    Fevera 0 0 0 1 (3%) 0 1 (2%) 0 2 (3%)
    Grade≥2 0 1 (2%) 0
Feverishnessb 4 (12%) 3 (9%) 3 (9%) 3 (9%) 7 (12%) 5 (9%) 3 (5%) 7 (12%)
    Grade≥2 1 (3%) 1 (3%) 1 (3%) 1 (3%) 1 (2%) 2 (4%) 0 4 (7%)
    Malaise 9 (26%) 5 (15%) 10 (28%) 3 (9%) 13 (22%) 9 (16%) 10 (16%) 11 (18%)
    Grade≥2 3 (9%) 2 (6%) 5 (14%) 1 (3%) 6 (10%) 0 0 8 (13%)
    Myalgia 5 (14%) 5 (15%) 7 (19%) 4 (12%) 9 (15%) 9 (17%) 13 (22%) 10 (16%)
    Grade≥2 1 (3%) 2 (6%) 7 (19%) 0 3 (5%) 1 (2%) 1 (2%) 5 (8%)
    Headache 7 (20%) 3 (9%) 11 (31%) 7 (21%) 17 (28%) 8 (15%) 15 (25%) 13 (22%)
    Grade≥2 2 (6%) 0 6 (17%) 0 6 (10%) 0 4 (7%) 5 (9%)
    Nausea 4 (12%) 3 (9%) 3 (9%) 3 (9%) 8 (13%) 4 (8%) 6 (10%) 6 (10%)
    Grade≥2 1 (3%) 1 (3%) 3 (9%) 1 (3%) 2 (3%) 2 (4%) 2 (3%) 2 (3%)
Injection site symptoms
    ≥1 symptom 6 (17%) 3 (9%) 10 (28%) 7 (21%) 21 (32%) 21 (38%) 34 (42%) 25 (40%)
    Grade ≥2 1 (3%) 0 0 0 2 (3%) 0 1 (2%) 1 (2%)
    Pain 4 (12%) 1 (3%) 7 (19%) 3 (9%) 10 (16%) 7 (13%) 15 (25%) 13 (22%)
    Grade ≥2 1 (3%) 0 0 0 2 (3%) 0 1 (2%) 1 (2%)
    Tenderness 6 (17%) 1 (3%) 7 (19%) 6 (18%) 13 (22%) 10 (18%) 24 (39%) 19 (32%)
    Grade ≥2 1 (3%) 0 0 0 0 0 0 1 (2%)
    Redness 2 (6%) 1 (3%) 0 1 (3%) 10 (17%) 11 (20%) 13 (21%) 0
    Grade ≥2 0 0 0 0 0 0
    Swelling 2 (6%) 0 0 0 7 (12%) 8 (15%) 7 (11%) 0
    Grade ≥2 0 0 0 0

Abbreviation: HA, hemagglutinin.

a

Fever indicates a self-measured oral temperature of at least 38°C.

b

Feverishness indicates the participants’ self-reported sense of feverishness.