Table 4 Adverse events after the first dose of the BNT162b2 Comirnaty vaccine in healthy adolescents and patients with autoimmune rheumatic diseases
After the first dose of the vaccine, n (%) | After the second dose of the vaccine, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
pARDa | Healthy adolescents | pARD | Healthy adolescents | |||||||
AEb | Yes | No | Yes | No | p-value | Yes | No | Yes | No | p-value |
AE – overall | 38 (88) | 5 (12) | 87 (95) | 5 (5) | 0.20 | 40 (93) | 3 (7) | 83 (90) | 9 (10) | 0.59 |
AE – local | 37 (86) | 6 (14) | 83 (90) | 9 (10) | 0.47 | 36 (84) | 7 (16) | 73 (79) | 19 (21) | 0.55 |
AE – systemic | 20 (47) | 23 (53) | 60 (65) | 32 (35) | 0.039 | 29 (67) | 14 (33) | 63 (68) | 29 (32) | 0.9 |
Local AE | ||||||||||
Pain at VSc | 37 (86) | 6 (14) | 80 (87) | 12 (13) | 0.88 | 36 (84) | 7 (16) | 71 (77) | 21 (23) | 0.38 |
Redness at VS | 3 (7) | 40 (93) | 8 (9) | 84 (91) | 0.73 | 3 (7) | 40 (93) | 7 (8) | 85 (92) | 0.9 |
Swelling at VS | 10 (23) | 33 (77) | 13 (14) | 79 (86) | 0.19 | 8 (19) | 35 (81) | 14 (15) | 78 (85) | 0.62 |
Itching at VS | 5 (12) | 38 (88) | 12 (13) | 80 (87) | 0.82 | 2 (5) | 41 (95) | 5 (5) | 87 (95) | 0.85 |
Tingling at VS | 0 (0) | 43 (100) | 5 (5) | 87 (95) | 0.18* | 0 (0) | 43 (100) | 5 (5) | 87 (95) | 0.18* |
Systemic AE | ||||||||||
Nausea | 3 (7) | 40 (93) | 13 (14) | 79 (86) | 0.23 | 4 (9) | 39 (91) | 13 (14) | 79 (86) | 0.43 |
Vomiting | 0 (0) | 43 (100) | 0 (0) | 92 (100) | 1* | 0 (0) | 43 (100) | 1 (1) | 91 (99) | 1* |
Runny nose | 0 (0) | 43 (100) | 5 (5) | 87 (95) | 0.18* | 3 (7) | 40 (93) | 5 (5) | 87 (95) | 0.72 |
Cough | 0 (0) | 43 (100) | 3 (3) | 89 (97) | 0.55* | 0 (0) | 43 (100) | 3 (3) | 89 (97) | 0.55* |
Myalgia | 8 (19) | 35 (81) | 29 (32) | 63 (68) | 0.12 | 13 (30) | 30 (70) | 28 (30) | 64 (70) | 0.98 |
Arthralgia | 2 (5) | 41 (95) | 6 (7) | 86 (93) | 0.67 | 6 (14) | 37 (86) | 9 (10) | 83 (90) | 0.47 |
Fever > 38 °C | 1 (2) | 42 (98) | 6 (7) | 86 (93) | 0.31 | 6 (14) | 37 (86) | 12 (13) | 80 (87) | 0.88 |
Chills | 2 (5) | 41 (95) | 10 (11) | 82 (89) | 0.24 | 7 (16) | 36 (84) | 15 (16) | 77 (84) | 1 |
Feeling unwell | 8 (19) | 35 (81) | 30 (33) | 62 (67) | 0.092 | 19 (44) | 24 (56) | 36 (39) | 56 (61) | 0.58 |
Headache | 8 (19) | 35 (81) | 18 (20) | 74 (80) | 0.9 | 18 (42) | 25 (58) | 31 (34) | 61 (66) | 0.36 |
Tiredness | 13 (30) | 30 (70) | 37 (40) | 55 (60) | 0.26 | 18 (42) | 25 (58) | 58 (63) | 34 (37) | 0.021 |
Weakness | 5 (12) | 38 (88) | 32 (35) | 60 (65) | 0.0050 | 11 (26) | 32 (74) | 40 (43) | 52 (57) | 0.046 |
Allergic reaction | 0 (0) | 43 (100) | 0 (0) | 92 (100) | 1* | 0 (0) | 43 (100) | 0 (0) | 92 (100) | 1* |
Hospitalization | 0 (0) | 43 (100) | 0 (0) | 92 (100) | 1* | 0 (0) | 43 (100) | 0 (0) | 92 (100) | 1* |