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Table 3 Incidence of solicited local and general symptoms reported during the 7-day period after each dose (Days 0–7 for dose 1, and Days 21–28 for dose 2), overall by participant (TVC)

From: Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03A-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study

   95% CI
Symptom Type N n % LL UL
Solicited local symptoms
Pain All 50 46 92 80.8 97.8
Grade 3 50 4 8 2.2 19.2
Redness All 50 6 12 4.5 24.3
Grade 3 50 0 0 0.0 7.1
Swelling All 50 7 14 5.8 26.7
Grade 3 50 0 0 0.0 7.1
Solicited general symptoms
Fatigue All 50 27 54 39.3 68.2
Grade 3 50 1 2 0.1 10.6
Gastrointestinal symptoms All 50 12 24 13.1 38.2
Grade 3 50 2 4 0.5 13.7
Headache All 50 20 40 26.4 54.8
Grade 3 50 2 4 0.5 13.7
Joint pain All 50 14 28 16.2 42.5
Grade 3 50 1 2 0.1 10.6
Muscle ache All 50 33 66 51.2 78.8
Grade 3 50 1 2 0.1 10.6
Shivering All 50 10 20 10.0 33.7
Grade 3 50 1 2 0.1 10.6
Sweating All 50 7 14 5.8 26.7
Grade 3 50 1 2 0.1 10.6
Temperature All 50 1 2 0.1 10.6
Grade 3 50 0 0 0.0 7.1
Grade 4 50 0 0 0.0 7.1
  1. N Number of participants with at least one documented dose, TVC Total vaccinated cohort
  2. Symptom intensity was graded on a scale of 1 (mild) to 3 (severe) for all symptoms except for body temperature which was graded on a scale of 1 to 4. Grade 3 symptoms were defined as follows: for redness or swelling, a diameter > 100 mm; for fever, body temperature ≥ 39.0–40.0 °C (grade 4: > 40.0 °C); and for all other events, preventing normal activities