Table E7.
Number of events of clinical symptoms and signs
| Symptoms/signs | Total events, N (rates per million doses [95% CI]) | Immediate hypersensitivity reactions, N (rates per million doses [95% CI]) | Immunization stress-related responses, N (rates per million doses [95% CI]) |
|---|---|---|---|
| Skin, facial, and oral symptoms/signs | |||
| Any type of rash∗ | 193 (160.6 [138.8-184.9]) | 193 (160.6 [138.8-184.9]) | 0 (0) |
| Angioedema∗ | 7 (5.8 [2.3-12.0]) | 7 (5.8 [2.3-12.0]) | 0 (0) |
| Pruritus∗ | 147 (122.3 [103.4-143.8]) | 147 (122.3 [103.4-143.8]) | 0 (0) |
| Mouth and throat discomfort | 179 (149.0 [127.9-172.4]) | 33 (27.5 [18.9-38.6]) | 146 (121.5 [102.6-142.9]) |
| Cardiovascular symptoms/signs | |||
| Palpitations | 298 (248.0 [220.6-277.8]) | 8 (6.7 [2.9-13.1]) | 290 (241.3 [214.4-270.8]) |
| Cold sweat | 125 (104.0 [86.6-123.9]) | 1 (0.8 [0-4.6]) | 124 (103.2 [85.8-123.0]) |
| Respiratory symptoms/signs | |||
| Wheezes or stridor∗ | 4 (3.3 [0.9-8.5]) | 4 (3.3 [0.9-8.5]) | 0 (0) |
| Hoarseness∗ | 1 (0.8 [0-4.6]) | 1 (0.8 [0-4.6]) | 0 (0) |
| Persistent cough∗ | 25 (20.8 [13.5-30.7]) | 25 (20.8 [13.5-30.7]) | 0 (0) |
| Shortness of breathing | 138 (114.8 [96.5-135.7]) | 13 (10.8 [5.8-18.5]) | 125 (104.0 [86.6-123.9]) |
| Chest pain | 37 (30.8 [21.7-42.4]) | 0 (0) | 37 (30.8 [21.7-42.4]) |
| Gastrointestinal symptoms/signs | |||
| Abdominal pain | 21 (17.5 [10.8-26.7]) | 3 (2.5 [0.5-7.3]) | 18 (15.0 [8.9-23.7]) |
| Nausea | 281 (233.8 [207.3-262.8]) | 12 (10.0 [5.2-17.4]) | 269 (223.9 [197.9-252.3]) |
| Vomiting | 14 (11.7 [6.4-19.5]) | 0 (0) | 14 (11.7 [6.4-19.5]) |
| Diarrhea | 2 (1.7 [0.2-6.0]) | 0 (0) | 2 (1.7 [0.2-6]) |
| Neurological symptoms/signs | |||
| Vertigo | 891 (741.5 [693.6-791.8]) | 8 (6.7 [2.9-13.1]) | 883 (734.8 [687.2-784.9]) |
| Syncope | 86 (71.6 [57.2-88.4]) | 0 (0) | 86 (71.6 [57.2-88.4]) |
| General weakness | 47 (39.1 [28.7-52.0]) | 2 (1.7 [0.2-6]) | 45 (37.4 [27.3-50.1]) |
| Numbness or loss of sensation | 411 (342.0 [309.8-376.7]) | 8 (6.7 [2.9-13.1]) | 403 (335.4 [303.4-369.8]) |
| Other symptoms/signs | |||
| Headache | 112 (93.2 [76.7-112.1]) | 3 (2.5 [0.5-7.3]) | 109 (90.7 [74.5-109.4]) |
| Malaise | 497 (413.6 [378-451.6]) | 11 (9.2 [4.6-16.4]) | 486 (404.4 [369.3-442]) |
| Hyperventilation/panic attack | 30 (25.0 [16.8-35.6]) | 1 (0.8 [0-4.6]) | 29 (24.1 [16.2-34.7]) |
| Photophobia | 28 (23.3 [15.5-33.7]) | 3 (2.5 [0.5-7.3]) | 25 (20.8 [13.5-30.7]) |
| Feeling of hot flush | 22 (18.3 [11.5-27.7]) | 0 (0) | 22 (18.3 [11.5-27.7]) |
| Abnormalities of vital signs | |||
| Hypotension | 458 (381.1 [347-417.7]) | 6 (5.0 [1.8-10.9]) | 452 (376.1 [342.3-412.5]) |
| Hypertension | 171 (142.3 [121.8-165.3]) | 32 (26.6 [18.2-37.6]) | 139 (115.7 [97.2-136.6]) |
| Bradycardia | 385 (320.4 [289.2-354.0]) | 10 (8.3 [4.0-15.3]) | 375 (312.1 [281.3-345.3]) |
| Tachycardia | 33 (27.5 [18.9-38.6]) | 6 (5.0 [1.8-10.9]) | 27 (22.5 [14.8-32.7]) |
| Tachypnoea | 40 (33.3 [23.8-45.3]) | 3 (2.5 [0.5-7.3]) | 37 (30.8 [21.7-42.4]) |
Data are presented as n (incidence rates per million doses [95% CI]).
CI, Confidence interval.
∗
Specific events for immediate hypersensitivity reactions. Hypotension: systolic blood pressure <90 mm Hg and/or diastolic blood pressure <60 mm Hg, hypertension: systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg, bradycardia: heart rate <60 beats per minute, tachycardia: heart rate >120 beats per minute and tachypnoea: respiratory rate >24 per min.