TABLE 3.

Summary of side effects according to severity in all patients and after excluding those who needed IC by proxy

Category	All patients, n (%)	Excluding those who needed IC by proxy a , n (%)
Any reaction after either dose	138 (80.7%)	109 (82.6%)
First dose	(N = 171)	(N = 132)
All	104 (60.8%)	85 (64.4%)
Grade 1	79 (46.2%)	69 (52.3%)
Grade 2	20 (11.7%)	13 (9.8%)
Grade ≥3	2 (1.2%)	2 (1.5%)
Fever (>38.5°C)	3 (1.8%)	2 (1.5%)
Second dose	(N = 170)	(N = 132)
All	115 (67.6%)	93 (70.5%)
Grade 1	83 (48.8%)	71 (53.8%)
Grade 2	27 (15.9%)	20 (15.2%)
Grade ≥3	3 (1.8%)	2 (1.5%)
Fever (>38.5°C)	5 (2.9%)	2 (1.5%)

^a Severity was defined according to the Common Terminology Criteria for Adverse Events version 5.0.

Abbreviation: IC, informed consent (parents or siblings).