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Table 5 Incidence of TIV reactogenicity events from Day 0 to Day 3 in the Safety Set

From: Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons

Symptom TIV
N = 3783 n (%)
Placebo
N = 3828 n (%)
P-value
At least 1 vaccine reactogenicity event 2487 (66) 1675 (44) <0.0001
Fever 96 (3) 55 (1) 0.0005
Injection site pain/soreness 1933 (51) 530 (14) <0.0001
Injection site redness 475 (13) 234 (6) <0.0001
Injection site swelling 418 (11) 109 (3) <0.0001
Myalgia and/or arthralgia 692 (18) 389 (10) <0.0001
Headache 683 (18) 716 (19) 0.5491
Tiredness 761 (20) 678 (18) 0.0049
Chills 158 (4) 136 (4) 0.1526
Malaise 338 (9) 236 (6) <0.0001
Red eyes 250 (7) 231 (6) 0.2772
Swelling of the face 51 (1) 37 (<1) 0.1327
Cough 286 (8) 250 (7) 0.0719
Chest tightness or difficulty in breathing 128 (3) 107 (3) 0.1274
Sore throat, hoarseness or pain on swallowing 324 (9) 344 (9) 0.5689
  1. >30 minutes post-vaccination
  2. Fisher's Exact test (p < 0.05 considered significant)
  3. Temperature ≥37.5°C/99.5°F