Table 2

Solicited local and systemic adverse effects within 7 days of receipt of first dose of adjuvanted or non-adjuvanted vaccines

EffectAdjuvanted vaccineNon-adjuvanted vaccine
Pandemrix (AS03) (N=295)Focetria (MF59) (N=175)FluvalP (aluminium phosphate) (N=29)Celvapan (N=76)
Local reaction
 Any reaction, n (%)160 (54.2)28 (16.0)8 (27.6)3 (3.9)
 Pain, n (%)151 (51.2)27 (15.4)8 (27.6)3 (3.9)
 Redness, n (%)26 (8.8)4 (2.3)0 (0)0 (0)
 Warmth, n (%)10 (3.4)0 (0)0 (0)0 (0)
 Swelling, n (%)33 (11.2)2 (1.1)0 (0)0 (0)
Systemic reaction
 Any reaction, n (%)64 (21.7)11 (6.3)0 (0)14 (18.4)
 Shivering, n (%)3 (1.0)1 (0.6)0 (0)0 (0)
 Fever ≥38°C, n (%)16 (5.4)2 (1.1)0 (0)4 (5.3)
 Unusual fatigue, n (%)24 (8.1)4 (2.3)0 (0)7 (9.2)
 Malaise, n (%)19 (6.4)1 (0.6)0 (0)5 (6.6)
 Headache, n (%)17 (5.8)3 (1.7)0 (0)1 (1.3)
 Muscle pain, n (%)15 (5.1)3 (1.7)0 (0)0 (0)
 Arthralgia, n (%)5 (1.7)1 (0.6)0 (0)1 (1.3)
 Use of pain killers, n (%)16 (5.4)0 (0)0 (0)1 (1.3)
Increased bowel movements per day, diarrhoea and/or bloody diarrhoea
 Any IBD, n (%)10 (3.4)5 (2.9)0 (0)7 (9.2)
 Crohn's disease, n8305
 Ulcerative colitis, n2202
 Indeterminate colitis, n0000
  • IBD, inflammatory bowel disease.