Table 2.
Adverse Events | First Dose | Second Dose | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Male (N = 152) | Female (N = 114) | F to M Ratio | 95% CI | p-Value | Male (N = 152) | Female (N = 114) | F to M Ratio | 95% CI | p-Value | |||||
n | % | n | % | n | % | n | % | |||||||
Local | ||||||||||||||
Swelling in the injection area | 8 | 5.3 | 22 | 19.3 | 3.64 | 1.58–8.54 | 0.0001 | 8 | 5.3 | 21 | 18.4 | 3.47 | 1.42–6.80 | 0.0001 |
Pain in the injection area | 41 | 27.0 | 69 | 60.0 | 2.22 | 1.42–3.54 | 0.0001 | 26 | 17.1 | 63 | 55.3 | 3.23 | 1.62–3.66 | 0.0001 |
Pain all over the injected hand | 6 | 3.0 | 24 | 21.1 | 7.03 | 1.93–10.88 | 0.0001 | 8 | 5.3 | 25 | 21.9 | 4.13 | 1.68–7.72 | 0.0001 |
Rash or redness in the injection area | 1 | 0.7 | 3 | 2.6 | 3.71 | 0.41–37.23 | 0.212 | 1 | 0.7 | 4 | 3.5 | 5.00 | 0.59–45.79 | 0.109 |
Systemic | ||||||||||||||
Fever | 0 | 0 | 3 | 2.6 | NA | NA | 0.078 | 15 | 9.9 | 19 | 16.7 | 1.69 | 0.84–3.01 | 0.073 |
Shivering | 2 | 1.3 | 13 | 11.4 | 8.77 | 1.81–34.28 | 0.0001 | 13 | 8.6 | 38 | 33.3 | 3.87 | 1.76–5.72 | 0.0001 |
Muscle pains | 5 | 3.3 | 19 | 16.7 | 5.06 | 1.72–11.79 | 0.0001 | 21 | 13.8 | 41 | 36.0 | 2.61 | 1.35–3.51 | 0.0001 |
Joint pains | 0 | 0 | 6 | 5.3 | NA | NA | 0.006 | 7 | 4.6 | 18 | 15.8 | 3.43 | 1.34–7.19 | 0.002 |
Headaches | 3 | 2.0 | 21 | 18.3 | 9.15 | 2.45–26.35 | 0.0001 | 15 | 9.9 | 37 | 32.5 | 3.28 | 1.56–4.77 | 0.0001 |
Fatigue | 10 | 6.6 | 25 | 21.9 | 3.32 | 1.45–5.85 | 0.0001 | 30 | 19.7 | 51 | 44.7 | 2.27 | 1.26–2.79 | 0.0001 |
Lack of ability to stand | 0 | 0 | 10 | 8.8 | NA | NA | 0.0001 | 1 | 0.7 | 19 | 16.7 | 23.86 | 2.97–161.09 | 0.0001 |
General weakness | 1 | 0.7 | 23 | 20.2 | 30.67 | 3.52–187.68 | 0.0001 | 19 | 12.5 | 37 | 32.5 | 2.60 | 1.33–3.67 | 0.0001 |
Allergy | 0 | 0 | 3 | 2.6 | NA | NA | 0.078 | 0 | 0 | 1 0.9) | 0.9 | NA | NA | 0.429 |
Anaphylaxis | 0 | 0 | 0 | 0 | NA | NA | NA | 0 | 0 | 0 | 0 | NA | NA | NA |
Sensory | ||||||||||||||
Paresthesia in the injected hand | 0 | 0 | 6 | 5.3 | NA | NA | 0.006 | 0 | 0 | 6 | 5.3 | NA | NA | 0.006 |
Facial paralysis | 0 | 0 | 1 | 0.9 | NA | NA | 0.3 | 0 | 0 | 1 | 0.9 | NA | NA | 0.429 |
Facial paresthesia | 0 | 0 | 2 | 1.8 | NA | NA | 0.183 | 0 | 0 | 2 | 1.8 | NA | NA | 0.183 |
Herpes zoster | 0 | 1 | 0.9 | NA | NA | 0.429 | 1 | 0.7 | 0 | 0 | NA | NA | 0.571 |