Table 2.
Systemic and local solicited adverse events within 28 days after vaccination with 1/10 and 1/5 dose of Sputnik V.
| 1/10 dose | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 12-14 y.o. (n=13) | 15-17 y.o. (n=33) | 12-17 y.o. (n=46) | |||||||
| Total | Grade 1 | Grade 2 | Total | Grade 1 | Grade 2 | Total | Grade 1 | Grade 2 | |
| Any symptom | 12 (92.3) | 12 (92.3) | 0 | 20 (60.6) | 20 (60.6) | 2 (6.1) | 32 (69.6) | 32 (69.6) | 2 (4.3) |
| With more than one AE | 5 (38.5) | 5 (38.5) | 0 | 7 (21.2) | 5 (15.2) | 2 (6.1) | 12 (26.1) | 10 (21.7) | 2 (4.3) |
| Any injection-site symptoms | 10 (76.9) | 10 (76.9) | 0 | 11 (33.3) | 11 (33.3) | 0 | 21 (45.7) | 21 (45.7) | 0 |
| Pain in injection site | 9 (69.2) | 9 (69.2) | 0 | 9 (27.3) | 9 (27.3) | 0 | 18 (39.1) | 18 (39.1) | 0 |
| Swelling | 1 (7.7) | 1 (7.7) | 0 | 2 (6.1) | 2 (6.1) | 0 | 3 (6.5) | 3 (6.5) | 0 |
| Redness | 1 (7.7) | 1 (7.7) | 0 | 2 (6.1) | 2 (6.1) | 0 | 3 (6.5) | 3 (6.5) | 0 |
| Any systemic symptoms | 5 (38.5) | 5 (38.5) | 0 | 13 (39.4) | 12 (36.4) | 2 (6.1) | 18 (39.1) | 17 (36.9) | 2 (4.3) |
| Flu-like syndrome | 0 | 0 | 0 | 3 (9.1) | 3 (9.1) | 0 | 3 (6.5) | 3 (6.5) | 0 |
| Headache | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Muscle and joint pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperthermia | 3 (23.1) | 3 (23.1) | 0 | 9 (27.3) | 9 (27.3) | 0 | 12 (26.1) | 12 (26.1) | 0 |
| Chills | 0 | 0 | 0 | 1 (3.0) | 1 (3.0) | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Decreased appetite | 1 (7.7) | 1 (7.7) | 0 | 0 | 0 | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnoramal laboratory values | 2 (15.4) | 2 (15.4) | 0 | 4 (12.1) | 3 (9.1) | 2 (6.1) | 6 (13.0) | 5 (10.9) | 2 (4.3) |
| 1/5 dose | |||||||||
| 12-14 y.o. (n=13) | 15-17 y.o. (n=32) | 12-17 y.o. (n=45) | |||||||
| Total | Grade 1 | Grade 2 | Total | Grade 1 | Grade 2 | Total | Grade 1 | Grade 2 | |
| Any symptom | 7 (53.8) | 7 (53.8) | 0 | 23 (71.9) | 22 (68.8) | 1 (3.1) | 30 (66.7) | 29 (64.4) | 1 (2.2) |
| With more than one AE | 0 | 0 | 0 | 8 (25) | 8 (25) | 0 | 8 (17.8) | 8 (17.8) | 0 |
| Any injection-site symptoms | 4 (30.8) | 4 (30.8) | 0 | 14 (43.8) | 13 (40.6) | 1 (3.1) | 18 (40.0) | 17 (37.8) | 1 (2.2) |
| Pain in injection site | 4 (30.8) | 4 (30.8) | 0 | 13 (40.6) | 12 (37.5) | 1 (3.1) | 17 (37.8) | 16 (35.6) | 1 (2.2) |
| Swelling | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Redness | 0 | 0 | 0 | 1 (3.1) | 1 (3.1) | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Any systemic symptoms | 3 (23.1) | 3 (23.1) | 0 | 15 (46.9) | 15 (46.9) | 0 | 18 (40.0) | 18 (40.0) | 0 |
| Flu-like syndrome | 1 (7.7) | 1 (7.7) | 0 | 2 (6.3) | 2 (6.3) | 0 | 3 (6.7) | 3 (6.7) | 0 |
| Headache | 0 | 0 | 0 | 2 (6.3) | 2 (6.3) | 0 | 2 (4.4) | 2 (4.4) | 0 |
| Muscle and joint pain | 0 | 0 | 0 | 2 (6.3) | 2 (6.3) | 0 | 2 (4.4) | 2 (4.4) | 0 |
| Hyperthermia | 2 (15.4) | 2 (15.4) | 0 | 10 (31.3) | 10 (31.3) | 0 | 12 (26.7) | 12 (26.7) | 0 |
| Chills | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Decreased appetite | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain | 0 | 0 | 0 | 1 (3.1) | 1 (3.1) | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Abnoramal laboratory values | 0 | 0 | 0 | 3 (9.4) | 3 (9.4) | 0 | 3 (6.7) | 3 (6.7) | 0 |
Participants who received each dose of vaccine were additionally divided into two age cohorts of 12–14 and 15–17y.o. This table shows the total number (%) of volunteers who developed solicited adverse events, based on the severity: mild [grade 1], moderate [grade 2], and no serious [grade 3] adverse events were reported. Some volunteers had several adverse events of different degrees of severity. Bold values represent summarized results of indicated groups of AEs.