Table 3.

Ten most frequently reported reactions according to age group

a. < 10 years (n = 18,022)
Seizure, n (%)	390 (2.2)
Anaphylactic reaction, n (%)	374 (2.1)
Abnormal behavior, n (%)	374 (2.1)
Hepatic function abnormal, n (%)	336 (1.9)
Pyrexia, n (%)	319 (1.8)
Anaphylactic shock, n (%)	271 (1.5)
Stevens-Johnson syndrome, n (%)	246 (1.4)
Rash, n (%)	229 (1.3)
Erythema multiforme, n (%)	195 (1.1)
Drug eruption, n (%)	156 (0.9)
b. 10–19 years (n = 15,157)
Abnormal behavior, n (%)	419 (2.8)
Anaphylactic shock, n (%)	353 (2.3)
Anaphylactic reaction, n (%)	333 (2.2)
Pyrexia, n (%)	236 (1.6)
Seizure, n (%)	223 (1.5)
Hepatic function abnormal, n (%)	220 (1.5)
Stevens-Johnson syndrome, n (%)	175 (1.2)
Drug reaction with eosinophilia and systemic symptoms, n (%)	171 (1.1)
Pancreatitis acute, n (%)	170 (1.1)
Rash, n (%)	169 (1.1)

Note: The terms are as described in Japanese version 21.0 of MedDRA®