Adverse event | Frequency reported at 3 months (N = 44) | Frequency reported at 6 months (N = 35) | Frequency reported at 12 months (N = 14) |
---|---|---|---|
Isolated cutaneous symptoms | 7/44 (15.9%) | 11/35 (31.4%) | 10/14 (71.4%) |
Any extracutaneous symptoms | 10/44 (22.7%) | 7/35 (20%) | 3/14 (21.4%) |
Cough | 2/44 (4.5%) | 0 (0%) | 1/14 (7.1%) |
Rhinitis | 2/44 (4.5%) | 0 (0%) | 3/14 (21.4%) |
Conjunctivitis | 1/44 (2.2%) | 1/35 (2.9%) | 2/14 (14.3%) |
Wheeze | 0 (0%) | 1/35 (2.9%) | 1/14 (7.1%) |
Vomiting | 2/44 (4.5%) | 4/35 (11.4%) | 2/14 (14,3%) |
Abdominal pain | 6/44(13.6%) | 3/35 (8.6%) | 1/14 (7.1%) |
Diarrhea | 2/44 (4.5%) | 2/35 (5.7%) | 0 (0%) |
Lethargy | 0 (0%) | 0 (0%) | 0 (0%) |
Dizziness/loss of consciousness | 0 (0%) | 0 (0%) | 0 (0%) |
Difficulty breathing | 0 (0%) | 0 (0%) | 0 (0%) |
Other symptoms | 3/44 (6.8%) | 3/35 (8.6%) | 4/14 (28.5%) |
Epinephrine administered | 1/44 (2.3%) | 0 (0%) | 1/14 (7.1%) |
Emergency room visit | 1/44 (2.3%) | 0 (0%) | 1/14 (7.1%) |