Table 2.
Distribution of Local Pain and Redness According to the Time of Observation and Severity Level
| No. | Adverse Event Following Immunization* | Post Marketing Surveillance, Jakarta, 2017 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 30’ | D1 | D2 | D3 | D4 | D5 | D6 | D7-28 | ||
| Local Reaction | |||||||||
| 1 | Pain (n= 298; 59.6%) | ||||||||
| Severity Time | 30’ | D1 | D2 | D3 | D4 | D5 | D6 | D7-28 | |
| Mild | 13.80% (n=69) | 15.20% (n=76) | 12.60% (n=63) | 14.20% (n=71) | 3% (n=15) | 1% (n=5) | 0.60% (n=3) | 2.80% (n=14) | |
| Moderate | 18.40% (n=92) | 15.80% (n=79) | 14.40%(n=72) | 7.60% (n=38) | 1% (n=5) | 0 | 0 | 0.80% (n=4) | |
| Severe | 12.40% (n=62) | 5.80% (n=29) | 4.40% (n=22) | 1% (n=5) | 0 | 0 | 0 | 0 | |
| 2 | Redness (n= 118; 23.6%) | ||||||||
| Severity Time | 30’ | D1 | D2 | D3 | D4 | D5 | D6 | D7-28 | |
| Mild | 18.80% (n=94) | 11.60% (n=58) | 9.60% (n=48) | 9.20% (n=46) | 6.40% (n=32) | 4.00% (n=20) | 2.00% (n=10) | 8.20% (n=41) | |
| Moderate | 2.60% (n=13) | 2.40% (n=12) | 0.40% (n=2) | 0 | 0.20% (n=1) | 0 | 0 | 0 | |
| Severe | 0.40% (n=2) | 0.40% (n=2) | 0 | 0 | 0.40% (n=2) | 0 | 0 | 0 | |
*
Adverse events were evaluated after 30 minutes (30’) and on days 1 to 28 (D1, D2, D3, D4, D5, D6, D7-28)