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. 2013 Nov 15;10(2):441–448. doi: 10.4161/hv.27140

Table 3. Local injection site and systemic reactions.

    Number (%) of subjects a
    18–60 y ≥61 y Total
    (n = 63) (n = 63) (n = 126)
Any   45 (71%) 31 (49%) 76 (60%)
Injection site reactions (Day 1 – Day 4 post vaccination)
Any   30 (48%) 22 (35%) 52 (41%)
Ecchymosis (mm) Any 1 (2%) 4 (6%) 5 (4%)
  >50 mm 0 0 0
Erythema (mm) Any 1 (2%) 0 1 (1%)
  >50 mm 0 0 0
Induration (mm) Any 0 2 (3%) 2 (2%)
  >50 mm 0 0 0
Swelling (mm) Any 1 (2%) 2 (3%) 3 (2%)
  >50 mm 0 0 0
Pain Any 29 (46%) 17 (27%) 46 (37%)
  Severe 0 0 0
Systemic reactions (Day 1–Day 4 post vaccination)
Any   39 (62%) 20 (32%) 59 (47%)
Chills/ shivering Any 1 (2%) 1 (2%) 2 (2%)
  Severe 0 0 0
Malaise Any 5 (8%) 2 (3%) 7 (6%)
  Severe 0 0 0
Myalgia Any 27 (43%) 12 (19%) 39 (31%)
  Severe 0 0 0
Arthralgia Any 2 (3%) 0 2 (2%
  Severe 0 0 0
Headache Any 13 (21%) 4 (6%) 17 (13%)
  Severe 0 0 0
Sweating Any 10 (16%) 7 (11%) 17 (13%)
  Severe 0 0 0
Fatigue Any 15 (24%) 7 (11%) 22 (17%)
  Severe 0 0 0
Fever   0 0 0
Other reactions        
Temperature <36 °C 3 (5%) 11 (17%) 14 (11%)
  ≥40 0 0 0

a Local injection site and systemic reactions were recorded for all subjects who provided post vaccination safety data (safety set)

HHS Vulnerability Disclosure