Table 2.
Day 3 | Day 7 | p-Value * | Day 14 | p-Value ± | ||||
---|---|---|---|---|---|---|---|---|
N° | % | N° | % | N° | % | |||
They presented adverse effects | 0.025 | <0.001 | ||||||
Only on the arm | 113 | 27.5 | 35 | 8.5 | 14 | 3.4 | ||
Systemic level only | 28 | 6.8 | 26 | 6.3 | 10 | 2.4 | ||
Both | 216 | 52.6 | 20 | 4.9 | 2 | 0.5 | ||
None | 54 | 13.1 | 330 | 80.3 | 385 | 93.7 | ||
Number of adverse effects in the arm | 0.321 | <0.001 | ||||||
0 | 82 | 20 | 356 | 86.6 | 395 | 96.1 | ||
1 | 251 | 61.1 | 50 | 12.2 | 16 | 3.9 | ||
2 or more | 78 | 18.9 | 5 | 1.2 | 0 | 0 | ||
Adverse effects on the arm | <0.001 | <0.001 | ||||||
Injection site pain | 323 | 78.6 | 49 | 11.9 | 15 | 3.7 | ||
Swelling at the injection site | 71 | 17.3 | 3 | 0.8 | 0 | 0 | ||
Swelling in the armpit, close to the injection area | 9 | 2.2 | 1 | 0.3 | 0 | 0 | ||
Another reaction | 11 | 2.7 | 7 | 1.7 | 1 | 0.2 | ||
Number of systemic adverse effects | <0.001 | <0.001 | ||||||
0 | 167 | 40.6 | 365 | 88.8 | 399 | 97 | ||
1 | 82 | 20 | 18 | 4.4 | 6 | 1.5 | ||
2 or more | 162 | 39.4 | 28 | 6.8 | 6 | 1.5 | ||
Systemic adverse effects | <0.001 | <0.001 | ||||||
Fatigue | 82 | 20 | 8 | 2 | 2 | 0.5 | ||
Headache | 84 | 20.5 | 12 | 2.9 | 4 | 1 | ||
Muscle pain | 113 | 27.5 | 11 | 2.7 | 2 | 0.5 | ||
Fever above 38 °C | 28 | 6.8 | 2 | 0.5 | 0 | 0 | ||
Fever less than 38 °C | 52 | 12.7 | 3 | 0.7 | 0 | 0 | ||
Nausea/vomiting | 13 | 3.2 | 2 | 0.5 | 0 | 0 | ||
Diarrhea | 13 | 3.2 | 2 | 0.5 | 0 | 0 | ||
General discomfort | 137 | 33.3 | 11 | 2.7 | 1 | 0.2 | ||
Widespread rash | 0 | 0 | 1 | 0.2 | 1 | 0.2 | ||
Rash on the face | 0 | 0 | 1 | 0.2 | 1 | 0.2 | ||
Chest pain | 16 | 3.9 | 5 | 1.2 | 2 | 0.5 | ||
Irregular pulse | 12 | 2.9 | 0 | 0 | 0 | 0 | ||
Difficulty breathing | 11 | 2.7 | 0 | 0 | 0 | 0 | ||
Drowsiness | 13 | 3.2 | 2 | 0.5 | 2 | 0.5 | ||
Another reaction | 47 | 11.4 | 21 | 5.1 | 5 | 1.2 |
* Difference obtained from comparing day 7 to day 3. ± Difference obtained from comparing day 14 to day 3.