Table 2. Solicited systemic symptoms reported by the 30 females within 7 days after during the 7-day post-vaccination with human papillomavirus-16/18 AS04-adjuvanted vaccine.
Symptom | Type | HPV vaccination |
Overall/subject |
Overall/dose |
|||||||
Dose 1 |
Dose 2 |
Dose 3 |
|||||||||
n* | % (95% CI) | n* | % (95% CI) | n† | % (95% CI) | n* | % (95% CI) | n‡ | % (95% CI) | ||
Arthralgia | All | 2 | 6.7 (0.8–22.1) | 2 | 6.7 (0.8–22.1) | 0 | 0.0 (0.0–11.9) | 2 | 6.7 (0.8–22.1) | 4 | 4.5 (1.2–11.1) |
Grade 3 | 0 | 0.0 (0.0–11.6) | 1 | 3.3 (0.1–17.2) | 0 | 0.0 (0.0–11.9) | 1 | 3.3 (0.1–17.2) | 1 | 1.1 (0.0–6.1) | |
Fatigue | All | 6 | 20.0 (7.7–38.6) | 7 | 23.3 (9.9–42.3) | 4 | 13.8 (3.9–31.7) | 10 | 33.3 (17.3–52.8) | 17 | 19.1 (11.5–28.8) |
Fever | All | 1 | 3.3 (0.1–17.2) | 1 | 3.3 (0.1–17.2) | 0 | 0.0 (0.0–11.9) | 2 | 6.7(0.8–22.1) | 2 | 2.2 (0.3–7.9) |
Gastro-intestinal | All | 1 | 3.3 (0.1–17.2) | 3 | 10.0 (2.1–26.5) | 0 | 0.0 (0.0–11.9) | 4 | 13.3 (3.8–30.7) | 4 | 4.5 (1.2–11.1) |
Headache | All | 6 | 20.0 (7.7–38.6) | 4 | 13.3 (3.8–30.7) | 2 | 6.9 (0.8–22.8) | 8 | 26.7 (12.3–45.9) | 12 | 13.5 (7.2–22.4) |
Grade 3 | 0 | 0.0 (0.0–11.6) | 1 | 3.3 (0.1–17.2) | 0 | 0.0 (0.0–11.9) | 1 | 3.3 (0.1–17.2) | 1 | 1.1 (0.0–6.1) | |
Myalgia | All | 5 | 16.7 (5.6–34.7) | 3 | 10.0 (2.1–26.5) | 2 | 6.9 (0.8–22.8) | 7 | 23.3 (9.9–42.3) | 10 | 11.2 (5.5–19.7) |
Grade 3 | 1 | 3.3 (0.1–17.2) | 1 | 3.3 (0.1–17.2) | 0 | 0.0 (0.0–11.9) | 1 | 3.3 (0.1–17.2) | 2 | 2.2 (0.3–7.9) | |
Rash | All | 0 | 0.0 (0.0–11.6) | 0 | 0.0 (0.0–11.6) | 1 | 3.4 (0.1–17.8) | 1 | 3.3 (0.1–17.2) | 1 | 1.1 (0.0–6.1) |
Footnotes as in Table 1. No cases of grade 3 fatigue, fever, gastrointestinal reaction, and rash and no cases of urticaria were reported.