Table 3.
Adverse events after the first and second doses of BNT162b2 vaccine in 390 pregnant women, according to the timing of vaccination during pregnancy
First dose | Second dose | |||||||
---|---|---|---|---|---|---|---|---|
Adverse event | 1st trimester (n = 76) | 2nd trimester (n = 193) | 3rd trimester (n = 121) | P | 1st trimester (n = 52) | 2nd trimester (n = 154) | 3rd trimester (n = 184) | P |
Local pain/swelling | 73 (96.1) | 181 (93.8) | 104 (86.0) | 0.02 | 48 (92.3) | 140 (90.9) | 172 (93.5) | 0.68 |
Rash | 0 (0) | 2 (1.0) | 1 (0.8) | 0.68 | 0 (0) | 2 (1.3) | 3 (1.6) | 0.65 |
Fever > 38°C | 1 (1.3) | 4 (2.1) | 1 (0.8) | 0.67 | 7 (13.5) | 13 (8.4) | 15 (8.2) | 0.48 |
Fever ≥ 39°C | 0 (0) | 0 (0) | 0 (0) | N/A | 1 (1.9) | 2 (1.3) | 0 (0) | 0.24 |
Severe fatigue | 20 (26.3) | 54 (28.0) | 26 (21.5) | 0.44 | 35 (67.3) | 89 (57.8) | 96 (52.2) | 0.14 |
Arthralgia | 0 (0) | 4 (2.1) | 0 (0) | 0.13 | 2 (3.8) | 10 (6.5) | 4 (2.2) | 0.14 |
Myalgia | 5 (6.6) | 14 (7.3) | 4 (3.3) | 0.34 | 15 (28.8) | 38 (24.7) | 41 (22.3) | 0.61 |
Axillary lymphadenopathy | 0 (0) | 0 (0) | 1 (0.8) | 0.33 | 3 (5.8) | 1 (0.6) | 4 (2.2) | 0.08 |
Paresthesia | 2 (2.6) | 5 (2.6) | 2 (1.7) | 0.85 | 3 (5.8) | 9 (5.8) | 6 (3.3) | 0.48 |
Headache | 5 (6.6) | 8 (4.1) | 5 (4.1) | 0.66 | 2 (3.8) | 21 (13.6) | 17 (9.2) | 0.11 |
Uterine contractions | 0 (0) | 2 (1.0) | 3 (2.5) | 0.29 | 0 (0) | 2 (1.3) | 23 (12.5) | < 0.001 |
Vaginal bleeding | 1 (1.3) | 0 (0) | 0 (0) | 0.13 | 2 (3.8) | 2 (1.3) | 2 (1.1) | 0.34 |
Prelabor rupture of membranes | 0 (0) | 0 (0) | 0 (0) | N/A | 0 (0) | 0 (0) | 3 (1.6) | 0.18 |
Data are given as n (%).
N/A, not applicable.