Table 4:
Local and systemic adverse events following any dose of trivalent inactivated influenza vaccine or inactivated polio vaccine
| Year 1 | Year 2 | Year 3 | ||||
|---|---|---|---|---|---|---|
| IPV (n=1730) | IIV3 (n=1632) | IPV (n=1825) | IIV3 (n=1718) | IPV (n=1796) | IIV3 (n=1673) | |
| Any reactions | 216 (13%) | 225 (14%) | 380 (21%) | 375 (22%) | 235 (13%) | 209 (12%) |
| Redness | 3 (<1%) | 3 (<1%) | 14 (1%) | 14 (1%) | 3 (<1%) | 1 (<1%) |
| Swelling | 13 (1%) | 21 (1%) | 48 (3%) | 71 (4%) | 11 (1%) | 16 (1%) |
| Tenderness at injection site | 72 (4%) | 77 (5%) | 229 (13%) | 236 (14%) | 145 (8%) | 118 (7%) |
| Vomiting | 8 (<1%) | 17 (1%) | 14 (1%) | 18 (1%) | 11 (1%) | 9 (1%) |
| Diarrhoea | 15 (1%) | 18 (1%) | 22 (1%) | 14 (1%) | 15 (1%) | 9 (1%) |
| Headache | 4 (<1%) | 11 (1%) | 3 (<1%) | 7 (<1%) | 0 | 1 (<1%) |
| Body ache | 3 (<1%) | 14 (1%) | 3 (<1%) | 7 (<1%) | 0 | 2 (<1%) |
| Fever | 113 (7%) | 122 (7%) | 161 (9%) | 154 (9%) | 93 (5%) | 99 (6%) |
| Irritability | 11 (1%) | 8 (<1%) | 9 (<1%) | 6 (<1%) | 2 (<1%) | 0 |
| Lethargy | 3 (<1%) | 4 (<1%) | 8 (<1%) | 12 (1%) | 2 (<1%) | 0 |
| Decreased feeding | 3 (<1%) | 2 (<1%) | 7 (<1%) | 9 (1%) | 1 (<1%) | 0 |
| Abnormal cry | 5 (<1%) | 3 (<1%) | 1 (<1%) | 5 (<1%) | 1 (<1%) | 1 (<1%) |
| Any serious adverse events | 0 | 0 | 0 | 0 | 0 | 0 |
| Any grade 2 or 3 reactions | 123 (7%) | 124 (8%) | 192 (11%) | 181 (11%) | 104 (6%) | 104 (6%) |
| Any grade 3 reactions | 64 (4%)* | 51 (3%)† | 65 (4%)‡ | 42 (2%)§ | 32 (2%)¶ | 40 (2%)‖ |
| Deaths** | 4 (<1%) | 5 (<1%) | 2 (<1%) | 3 (<1%) | 1 (<1%) | 0 |
Data are n (%). IPV=inactivated poliovirus vaccine. IIV3=trivalent inactivated influenza vaccine.
69 grade 3 reactions among 64 children: fever (n=47), tenderness at injection site (n=8), abnormal cry (n=5), vomiting (n=4), diarrhea (n=3), headache (n=1), and irritability (n=1).
64 grade 3 reactions among 51 children: fever (n=35), body ache (n=5), vomiting (n=5), diarrhoea (n=5), tenderness at injection site (n=4), swelling (n=3), abnormal cry (n=3), headache (n=3), and irritability (n=1).
70 grade 3 reactions among 65 children: fever (n=37), tenderness at injection site (n=23), vomiting (n=3), diarrhoea (n=2), headache (n=1), body ache (n=1), irritability (n=1), decreased feeding (n=1), and abnormal cry (n=1). §47 grade 3 reactions among 42 children: fever (n=19), tenderness at injection site (n=18), abnormal cry (n=5), vomiting (n=2), diarrhoea (n=1), headache (n=), body ache (n=1), and decreased feeding (n=1).
34 grade 3 reactions among 32 children: fever (n=16), tenderness at injection site (n=11), vomiting (n=3), diarrhea (n=3), and abnormal cry (n=1).
46 grade 3 reactions among 40 children: fever (n=24), tenderness at injection site (n=14), vomiting (n=3), diarrhoea (n=3), swelling (n=1), and abnormal cry (n=1).
No deaths were vaccine-related.