Table 3 Comparison of reporting rates for all suspected adverse drug reactions in the 2019/2020 enhanced passive safety surveillance with the reporting rates recorded in the Summary of Product Characteristics
Current EPSS NH 2019/2020 EPSS (irrespective of time to ADR onset)a | Vaxigrip Tetra® (Sanofi Pasteur) SmPC | Higher when compared with SmPC | |||
|---|---|---|---|---|---|
MedDRA preferred term | Reported frequency (95% CI) | Corresponding ADR terms | Frequency categories if available in SmPC (eg, common, rare) | ||
PRAC ADR of interest: decreased appetite | Decreased appetite | 0.11 (0.00, 0.59) (in adults) | Appetite lost | Not available in the SmPC for adults and elderly | Not applicable |
PRAC ADR of interest: injection-site reactions | Vaccination-site warmth | 0.11 (0.00, 0.59) (in adults) | Injection-site warmth | Uncommon (≥0.1 to < 1%) in children 3 to 8 years of age, adults and elderly | No |
PRAC ADR of interest: myalgia/arthralgia | Joint lockb | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPCc | Not applicable | |
Musculoskeletal stiffnessb | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPCc | Not applicable | ||
PRAC ADR of interest: rash | Rash | 0.21 (0.03, 0.77) | Rash | Not available in the SmPC for children ≥3 years of age, adults and elderly. Rare (≥0.01 to < 0.1%) for children from 6 to 35 months | Not applicable |
Other ADRs: general disorders and administration site conditions | Adverse drug reaction | 1.28 (0.56, 2.00) (≥13 years of age to elderly) | Not available in the SmPCc | Not applicable | |
Asthenia | 0.11 (0.00, 0.59) (in adults) | Asthenia | Rare (≥0.01 to < 0.1%) | Yes | |
Inflammation | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPC for adults and elderly | Not applicable | ||
Secretion discharge | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPC for adults and elderly | Not applicable | ||
Sluggishness | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPC for adults and elderly | Not applicable | ||
Swellingd | 0.21 (0.03, 0.77) (in adults) | Not available in the SmPCc | Not applicable | ||
Tenderness | 0.11 (0.00, 0.59) (in elderly) | Injection-site pain | Very common (≥10%) in adults and elderly | No | |
Other ADRs: infections and infestations | Influenza | 0.43 (0.12, 1.09) (in adults) | As with any vaccine, vaccination with Vaxigrip Tetra® (Sanofi Pasteur) may not protect all vaccinees | Not available in the SmPCc | Not applicable |
Other ADRs: musculoskeletal and connective tissue disorders | Neck pain | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPCc | Not applicable | |
Other ADRs: nervous system disorders | Somnolence | 0.11 (0.00, 0.59) (in adults) | Somnolence | Rare (≥0.01 to < 0.1%) | Yes |
Other ADRs: psychiatric disorders | Delusion | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPCc | Not applicable | |
Other ADRs: respiratory, thoracic, and mediastinal disorders | Wheezing | 0.11 (0.00, 0.59) (in adults) | Not available in the SmPCc | Not applicable | |
Other ADRs: skin and subcutaneous tissue disorders | Erythema | 0.11 (0.00, 0.59) (in adults) | Hypersensitivity, allergic reactions such as erythema, urticaria, pruritus, pruritus generalized, dermatitis allergic, angioedema | Rare (≥0.01 to < 0.1%) in adults | Yes |
Other ADRs: vascular disorders | Flushing | 0.11 (0.00, 0.59) (in adults) | Hot flush | Uncommon (≥0.1 to < 1%) | No |