Table 4. Most frequently reported PRAC adverse events of interest (events reported at least twice) with onset within 7 days, by severity, United Kingdom and Finland, 2015/16 (n = 2,029).
| Preferred term | Mild | Moderate | Severe | Unknown | Total | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | % | 95% CI | n | % | 95% CI | n | % | 95% CI | n | % | 95% CI | n | % | 95% CI | |
| Vaxigrip (n = 1,012) | |||||||||||||||
| Number of vaccinees with PRAC AEI | 9 | 0.9 | 0.3–1.5 | 3 | 0.3 | 0.1–0.9 | 5 | 0.5 | 0.1–0.9 | 9 | 0.9 | 0.3–1.5 | 22 | 2.2 | 1.3–3.1 |
| Headache | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0.1 | 0.0–0.5 | 4 | 0.4 | 0.1–1.0 | 5 | 0.5 | 0.1–0.9 |
| Pyrexia | 3 | 0.3 | 0.1–0.9 | 1 | 0.1 | 0.0–0.5 | 2 | 0.2 | 0.0–0.7 | 3 | 0.3 | 0.1–0.9 | 9 | 0.9 | 0.3–1.5 |
| Vaccination site erythema | 1 | 0.1 | 0.0–0.5 | 1 | 0.1 | 0.0–0.5 | 2 | 0.2 | 0.0–0.7 | 1 | 0.1 | 0.0–0.5 | 5 | 0.5 | 0.1–0.9 |
| Intanza 15 µg (n = 1,017) | |||||||||||||||
| Number of vaccinees with PRAC AEI | 18 | 1.8 | 1.0–2.6 | 2 | 0.2 | 0.0–0.7 | 3 | 0.3 | 0.1–0.9 | 7 | 0.7 | 0.2–1.2 | 26 | 2.6 | 1.6–3.5 |
| Malaise | 3 | 0.3 | 0.1–0.9 | 0 | 0 | 0 | 1 | 0.1 | 0.0–0.5 | 2 | 0.2 | 0.0–0.7 | 6 | 0.6 | 0.1–1.1 |
| Vaccination site erythema | 6 | 0.6 | 0.1–1.1 | 1 | 0.1 | 0.0–0.5 | 0 | 0 | 0 | 2 | 0.2 | 0.0–0.7 | 9 | 0.9 | 0.3–1.5 |
| Vaccination site pain | 9 | 0.9 | 0.3–1.5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0.1 | 0.0–0.5 | 10 | 1.0 | 0.4–1.6 |
| Vaccination site pruritus | 4 | 0.4 | 0.1–1.0 | 0 | 0 | 0 | 1 | 0.1 | 0.0–0.5 | 0 | 0 | 0 | 5 | 0.5 | 0.1–0.9 |
| Vaccination site swelling | 5 | 0.5 | 0.1–0.9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0.5 | 0.1–0.9 |
AEI: adverse event of interest; PRAC: pharmacovigilance risk assessment committee.
Note: PRAC AEIs as listed in the guidance were specifically described as follows: Injection site reactions (pain, erythema, pruritus, swelling, induration and ecchymosis) and systemic reactions (fever > 38 °C, headache, malaise, myalgia, shivering, rash, vomiting, nausea, arthralgia, decreased appetite, irritability (for vaccinees younger than 5 years), crying (for vaccinees younger than 5 years), and events indicative of allergic and hypersensitivity reactions including ocular symptoms).