Table 3.
Vaccinee reporting rate by PRAC adverse drug reactions occurring within 7 days after vaccination
| Total number of VCs distributed N = 1008 | ||
|---|---|---|
| n | (%) (95% CI) | |
| PRAC ADRs of interest | 72 | 7.14 (5.63, 8.91) |
| Injection site reactions | 45 | 2.18 (1.37, 3.29) |
| Vaccination site pain | 19 | 1.88 (1.14, 2.93) |
| Vaccination site erythema | 15 | 1.49 (0.84, 2.44) |
| Vaccination site swelling | 11 | 1.09 (0.55, 1.94) |
| Myalgia | 9 | 0.89 (0.41, 1.69 |
| Headache | 7 | 0.69 (0.28, 1.43) |
| Fever | 3 | 0.30 (0.06, 0.87) |
| Nausea | 3 | 0.30 (0.06, 0.87) |
| Arthralgia | 2 | 0.20 (0.02, 0.71) |
| Malaise | 2 | 0.20 (0.02, 0.71) |
| Allergic and hypersensitivity reactions | 1 | 0.10 (0.00, 0.55) |
ADR, adverse drug reaction; CI, confidence interval; PRAC, Pharmacovigilance Risk Assessment Committee (PRAC ADRs of interest were ADRs recognized as being of particular interest by the Pharmacovigilance Risk Assessment Committee); VC, vaccination card