Table 4.
Cumulative participants (%) reporting AEIs (in italics) and/or other AEs post-dose 2 classified by MedDRA primary system organ class over the study period (safety set)
| MedDRA primary system organ class (code) Preferred term (code) |
Spain N = 96 | |
|---|---|---|
| n | % [95% CI, LL–UL] | |
| Any | 13 | 13.5 [7.4–22.0] |
| General disorders and administration site conditions (10018065) | 11 | 11.5 [5.9–19.6] |
| Injection site pain (10022086) | 7 | 7.3 [3.0–14.5] |
| Injection site swelling (10053425) | 3 | 3.1 [0.7–8.9] |
| Fatigue (10016256) | 2 | 2.1 [0.3–7.3] |
| Respiratory, thoracic and mediastinal disorders (10038738) | 2 | 2.1 [0.3–7.3] |
| Rhinorrhoea (10039101) | 2 | 2.1 [0.3–7.3] |
| Gastrointestinal disorders (10017947) | 2 | 2.1 [0.3–7.3] |
| Diarrhoea (10012735) | 1 | 1.0 [0.0–5.7] |
| Vomiting (10047700) | 1 | 1.0 [0.0–5.7] |
| Metabolism and nutrition disorders (10027433) | 1 | 1.0 [0.0–5.7] |
| Decreased appetite (10061428) | 1 | 1.0 [0.0–5.7] |
| Psychiatric disorders (10037175) | 1 | 1.0 [0.0–5.7] |
| Irritability (10022998) | 1 | 1.0 [0.0–5.7] |
| Skin and subcutaneous tissue disorders (10040785) | 1 | 1.0 [0.0–5.7] |
| Pruritus (10037087) | 1 | 1.0 [0.0–5.7] |
In italics: predefined adverse events of interest (AEIs) listed on the adverse drug reaction (ADR) card
AE adverse event, Any at least one symptom experienced (regardless of the MedDRA preferred term) under the specified system organ class, MedDRA medical dictionary for regulatory activities, N total number of participants vaccinated with GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) who received an ADR card, n/% number/percentage of participants vaccinated with GSK’s IIV4 reporting the symptom at least once on their ADR card, 95% CI, LL-UL 95% confidence interval (Clopper–Pearson exact CI not extended for clustered data), lower limit–upper limit