Table 2.

Solicited Adverse Events within the First Week After Vaccination with RV5 Vaccine

Timing	Adverse Event	No. (%) of Adverse Events
		Group A (N = 33)	Group B (N = 33)	Subgroups
				B-1 (14- to 20- day-olds) (N = 10)	B-2 (21- to 41-day-olds) (N = 23)
After dose 1	Fevera	0 (0)	0 (0)	0 (0)	0 (0)
	Vomiting	2 (6.1)	5 (15.2)	3 (30)	2 (9)
	Diarrhea	2 (6.1)	7 (21.2)	1 (10)	6 (27.3)
After dose 2b	Fever	1(3.6)	0 (0)	0 (0)	0 (0)
	Vomiting	1(3.6)	6 (18.8)	4 (40)	2 (9.1)
	Diarrhea	3 (10.7)	5 (15.6)	3 (30)	2 (9.1)
After dose 3c	Fever	1(3.6)	1(3.4)	0 (0)	1 (5)
	Vomiting	2 (7.1)	3 (10.3)	1 (11.1)	2 (10)
	Diarrhea	4 (14.3)	5 (17.2)	2 (22.2)	3 (15)
After any dose	Fever	2 (6.1)	1 (3)	0 (0)	1 (4.3)
	Mildd	1 (3)	0 (0)	0 (0)	0 (0)
	Moderate	1 (3)	1 (3)	0 (0)	1 (4.3)
	Severe	0 (0)	0 (0)	0 (0)	0 (0)
	Vomitinge	5 (15.2)	8 (24.2)	5 (50)	3 (13)
	Mildf	3 (9)	5 (15.2)	4 (40)	1 (4.3)
	Moderate	1 (3)	2 (6)	1 (10)	1 (4.3)
	Severe	1 (3)	1 (3)	0 (0)	1 (4.3)
	Diarrheag	7 (21.2)	13 (39.4)	4 (40)	9 (39.1)
	Mild	4 (12.1)	7 (21.2)	1 (10)	6 (26.1)
	Moderate	2 (6)	5 (15.2)	3 (30)	3 (13)
	Severe	1 (3)	1 (3)	0 (0)	0 (0)

Abbreviation: RV5, pentavalent rotavirus vaccine.

^aFever was defined as an axillary temperature of ≥100.4°F.

^bSubjects with missing values were excluded from analysis (group A, n = 28; group B, n = 32).

^cSubjects with missing values were excluded from analysis (group A, n = 28; group B, n = 29).

^dFever was graded as mild (100.4–100.9°F), moderate (101.0–101.6°F), or severe (≥101.7°F).

^eUsing the Fisher exact test, P = .54 for group A versus group B, whereas P = .036 for subgroup B-1 versus subgroup B-2.

^fVomiting and diarrhea were graded as mild (aware of symptoms, but easily tolerated), moderate (acting like something wrong), or severe (extremely distressed or unable to do usual activities).

^gNone of the subjects reported hematochezia.