Table 3.

Frequency of AEIs from AERC and EHR data combined (all ages) and summary of product characteristics solicited events by age group.

	Observed frequency SmPC by age group				Observed frequency ESS
AEIs	6mo–3y	3–6y	6–18y	≥18y	All age groups
General disorders and administration site conditions					% [95%CI, LL-UL]
Fever	Common	Common	Common	Common	Uncommon 0.43 [0.25–0.67]
Fatigue	N/A	N/A	Very common	Very common	Common 1.52 [1.14–1.97]
Injection site redness	Very common	Very common	Very common	Common	Commona 1.61 [1.20–2.11]
Nervous system disorders
Headache	N/A	N/A	Common	Common	Common 1.65 [1.14–2.31]
Drowsiness	Very common	Common	N/A	Uncommon	Uncommon 0.65 [0.33–1.16]
Psychiatric disorders
Irritability	Very common	Very common	N/A	N/A	Uncommon 0.25 [0.12–0.45]
Musculoskeletal disorders
Myalgia	N/A	N/A	Very common	Very common	Common 2.76 [2.20–3.42]
Arthralgia	N/A	N/A	Common	Common	Uncommon 0.87 [0.57–1.27]
Gastrointestinal disorders
Nausea	N/A	N/A	Common	Common	Uncommon 0.72 [0.42–1.14]
Vomiting	N/A	N/A	Common	Common	Uncommon 0.18 [0.12–0.27]
Diarrhea	N/A	N/A	Common	Common	Uncommon 0.68 [0.55–0.84]
Metabolism and nutrition disorders
Loss of appetite	Very common	Common	N/A	N/A	Uncommon 0.44 [0.30–0.64]
Skin and subcutaneous tissue disorders
Rash	N/R	Uncommon	Uncommon	N/A	Uncommon 0.45 [0.32–0.62]

AEIs for Fluarix Tetra in the different age groups are listed per dose according to the following frequency categories in the SmPC:¹⁰ Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; Very rare: <1/10,000

^aIn the study this event was captured under local erythema; AEI: Adverse event of interest; AERC: Adverse event recording card; EHR: electronic health record; ESS: enhanced safety surveillance; N/A = Not solicited in this age group; N/R = Not reported; SmPC: Summary of Product Characteristics; 95% CI: 95% Confidence interval (Clopper-Pearson exact CI modified for cluster data); LL: lower limit; UL: upper limit.