. Author manuscript; available in PMC: 2013 Sep 4.

Published in final edited form as: N Engl J Med. 2011 Dec 8;365(23):2178–2187. doi: 10.1056/NEJMoa1101245

Table 1. Frequency of Solicited Reports of Adverse Events during the First 7 Days after Vaccine Administration, According to Study Group^*.

Event	Vaccine				Placebo^†
	First Dose (N = 50)		Second Dose (N = 47)		First Dose (N = 47)		Second Dose (N = 43)
	no.	% (95% CI)	no.	% (95% CI)	no.	% (95% CI)	no.	% (95% CI)
Local symptoms
Nasal discomfort	7	14 (6–27)	5	11 (4–23)	2	4 (1–15)	2	5 (1–16)
Nasal discharge	15	30 (18–45)	15	32 (19–47)	16	34 (21–49)	10	23 (12–39)
Nasal stuffiness	15	30 (18–45)	11	23 (12–38)	12	26 (14–40)	8	19 (8–33)
Nasal itching	7	14 (6–27)	10	21 (11–36)	10	21 (11–36)	5	12 (4–25)
Sneezing	11	22 (12–36)	16	34 (21–49)	11	23 (12–38)	9	21 (10–36)
Blood-tinged mucus	1	2 (0–11)	0	0 (0–8)	1	2 (0–11)	0	0 (0–8)
Nasal bleeding	0	0 (0–7)	0	0 (0–8)	0	0 (0–8)	0	0 (0–8)
Any local symptom	22	44 (30–59)	22	47 (32–62)	23	49 (34–64)	13	30 (17–46)
Systemic symptoms
Fever	0	0 (0–7)	0	0 (0–8)	2	4(1–15)	0	0 (0–8)
Fatigue or malaise	9	18 (9–31)	1	2 (0–11)	7	15 (6–28)	2	5 (1–16)
Headache	16	32 (20–47)	8	17 (8–31)	14	30 (17–45)	9	21 (10–36)
Nausea	7	14 (6–27)	2	4 (1–15)	6	13 (5–26)	3	7 (2–19)
Loss of appetite	5	10 (3–22)	1	2 (0–11)	5	11 (4–23)	2	5 (1–16)
Abdominal cramps	6	12 (5–24)	3	6 (1–18)	7	15 (6–28)	4	9 (3–22)
Vomiting (≥1 episode)	0	0 (0–7)	0	0 (0–8)	2	4(1–15)	0	0 (0–8)
Diarrhea
Any	1	2 (0–11)	0	0 (0–8)	1	2 (0–11)	0	0 (0–8)
≥2 loose or liquid stools	5	10 (3–22)	6	13 (5–26)	10	21 (11–36)	10	23 (12–39)
Any systemic symptom	26	52 (37–66)	12	26 (14–40)	24	51 (36–66)	16	37 (23–53)
Any systemic or local symptom	33	66 (51–79)	29	62 (46–76)	33	70 (55–83)	21	49 (33–65)

CI denotes confidence interval.

^†

Data were not available during the follow-up period for one participant in the placebo group.

Table 1. Frequency of Solicited Reports of Adverse Events during the First 7 Days after Vaccine Administration, According to Study Group*.