Table 2.
Solicited Adverse Events (AEs) During the 7 Days After Receipt of Vaccine, by Vaccine Type and AE Severity Gradea
| Adverse Event | Intramuscular Vaccine (n=200), No. (%; 95% Confidence Interval) |
Intradermal Vaccine (n=200), No. (%; 95% Confidence Interval) |
||
|---|---|---|---|---|
| Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | |
| Injection-site reactions | ||||
| Pain | 26 (13; 9–18) | 0 | 26 (13; 9–18) | 0 |
| Redness | 5 (3; 1–6) | 0 | 84 (42; 35–49) | 0 |
| Swelling | 5 (3; 1–6) | 0 | 120 (60; 53–67) | 0 |
| Tenderness | 38 (19; 14–25) | 0 | 73 (37; 30–44) | 0 |
| Any injection- site reaction |
53 (27; 21–33) | 0 | 153 (77; 70–82) | 0 |
| Systemic reactions | ||||
| Feverishness | 30 (15; 10–21) | 2 (1; 0–2) | 20 (10; 6–15) | 1 (1; 0–3) |
| Malaise | 45 (23; 17–29) | 3 (2; 0–4) | 55 (28; 21–34) | 2 (1; 0–4) |
| Myalgia | 40 (20;15–26) | 5 (3; 0–6) | 61 (31; 24–37) | 1 (1; 0–3) |
| Headache | 39 (20; 14–26) | 4 (2; 0–4) | 47 (24; 18–30) | 2 (1; 0–4) |
| Nausea | 21 (11; 7–16) | 0 | 22 (11; 7–16) | 1 (1; 0–3) |
| Itching | 16 (8; 5–13) | 2 (1; 0–4) | 20 (10; 6–15) | 0 |
| Any systemic reaction |
90 (45; 38–52) | 7 (4; 1–7) | 101 (51; 43–58) | 4 (2; 1–5) |
| Any adverse event | 112 (56; 49–63) | 7 (4; 1–7) | 169 (85; 79–89) | 4 (2; 1–5) |
a
Grade 1 = mild (no interference with activity); grade 2 = moderate (some interference with activity); grade 3 = severe (prevents daily activity); grade 4 = life-threatening (emergency department visit or hospitalization).