Table 5.
Cumulative incidence rates of AEIs reported on the EHR or by AERC within the 7 days post-vaccination period by vaccine group according to EMA-specified clinical category (week 37–48).
|
Fluarix Tetra N = 13,861 |
Non-GSK N = 2295 |
Unknown brand N = 3178 |
All vaccinated N = 19,334 |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95% CI |
95% CI |
95% CI |
95% CI |
|||||||||||||
| AEIs | n | % | LL | UL | n | % | LL | UL | n | % | LL | UL | n | % | LL | UL |
| Any AEIs | 1049 | 7.60 | 6.43 | 8.96 | 62 | 2.59 | 1.93 | 3.47 | 54 | 1.77 | 1.42 | 2.20 | 1165 | 6.04 | 5.05 | 7.22 |
| Fever/pyrexia | 133 | 0.97 | 0.80 | 1.18 | 25 | 1.20 | 1.06 | 1.36 | 16 | 0.46 | 0.26 | 0.83 | 174 | 0.91 | 0.74 | 1.12 |
| Local symptoms (i.e. local erythema) | 127 | 0.92 | 0.57 | 1.47 | 0 | - | - | - | 0 | - | - | - | 127 | 0.69 | 0.40 | 1.16 |
| Any general non-specific symptoms | 202 | 1.45 | 1.14 | 1.84 | 1 | 0.09 | 0.07 | 0.12 | 1 | 0.03 | 0.00 | 0.21 | 204 | 1.05 | 0.80 | 1.38 |
| Drowsiness | 72 | 0.52 | 0.38 | 0.70 | 0 | - | - | - | 0 | - | - | - | 72 | 0.37 | 0.26 | 0.52 |
| Fatigue | 169 | 1.20 | 0.94 | 1.54 | 0 | - | - | - | 1 | 0.03 | 0.00 | 0.21 | 170 | 0.87 | 0.64 | 1.17 |
| Irritability | 17 | 0.12 | 0.07 | 0.20 | 0 | - | - | - | 0 | - | - | - | 17 | 0.09 | 0.05 | 0.14 |
| Malaise | 4 | 0.03 | 0.01 | 0.08 | 1 | 0.09 | 0.07 | 0.12 | 0 | - | - | - | 5 | 0.03 | 0.01 | 0.06 |
| Any respiratory/miscellaneous | 513 | 3.66 | 2.95 | 4.52 | 23 | 0.83 | 0.68 | 1.01 | 13 | 0.34 | 0.16 | 0.71 | 549 | 2.73 | 2.22 | 3.36 |
| Conjunctivitis | 28 | 0.19 | 0.10 | 0.35 | 2 | 0.10 | 0.09 | 0.12 | 0 | - | - | - | 30 | 0.14 | 0.07 | 0.25 |
| Coryza | 96 | 0.64 | 0.41 | 1.01 | 0 | - | - | - | 0 | - | - | - | 96 | 0.44 | 0.28 | 0.68 |
| Cough | 210 | 1.53 | 1.18 | 2.00 | 17 | 0.59 | 0.48 | 0.72 | 13 | 0.34 | 0.16 | 0.71 | 240 | 1.22 | 0.97 | 1.52 |
| Epistaxis | 12 | 0.09 | 0.04 | 0.16 | 1 | 0.09 | 0.07 | 0.12 | 0 | - | - | - | 13 | 0.07 | 0.04 | 0.12 |
| Hoarseness | 71 | 0.51 | 0.37 | 0.69 | 0 | - | - | - | 0 | - | - | - | 71 | 0.36 | 0.27 | 0.48 |
| Nasal congestion | 276 | 1.87 | 1.42 | 2.45 | 3 | 0.17 | 0.04 | 0.63 | 0 | - | - | - | 279 | 1.38 | 0.98 | 1.94 |
| Oropharyngeal pain | 155 | 1.10 | 0.83 | 1.45 | 2 | 0.09 | 0.02 | 0.36 | 0 | - | - | - | 157 | 0.78 | 0.59 | 1.03 |
| Rhinorrhoea | 243 | 1.69 | 1.32 | 2.16 | 2 | 0.11 | 0.02 | 0.68 | 0 | - | - | - | 245 | 1.23 | 0.90 | 1.68 |
| Wheezing | 63 | 0.45 | 0.28 | 0.73 | 0 | - | - | - | 1 | 0.03 | 0.01 | 0.19 | 64 | 0.31 | 0.20 | 0.47 |
| Any gastrointestinal | 154 | 1.09 | 0.85 | 1.39 | 2 | 0.10 | 0.08 | 0.12 | 3 | 0.10 | 0.03 | 0.32 | 159 | 0.80 | 0.60 | 1.08 |
| Decreased appetite | 50 | 0.35 | 0.24 | 0.51 | 1 | 0.04 | 0.01 | 0.32 | 1 | 0.03 | 0.00 | 0.26 | 52 | 0.26 | 0.17 | 0.40 |
| Diarrhoea | 64 | 0.46 | 0.36 | 0.59 | 0 | - | - | - | 2 | 0.06 | 0.02 | 0.26 | 66 | 0.34 | 0.26 | 0.45 |
| Nausea | 71 | 0.51 | 0.38 | 0.67 | 0 | - | - | - | 0 | - | - | - | 71 | 0.36 | 0.26 | 0.50 |
| Vomiting | 19 | 0.14 | 0.09 | 0.21 | 1 | 0.09 | 0.07 | 0.12 | 0 | - | - | - | 20 | 0.10 | 0.07 | 0.15 |
| Any sensitivity/anaphylaxis | 15 | 0.10 | 0.05 | 0.21 | 1 | 0.09 | 0.07 | 0.12 | 0 | - | - | - | 16 | 0.08 | 0.04 | 0.16 |
| Anaphylactic reactions | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - |
| Facial oedema | 1 | 0.01 | 0.00 | 0.05 | 0 | - | - | - | 0 | - | - | - | 1 | 0.01 | 0.00 | 0.03 |
| Hypersensitivity reactions | 14 | 0.09 | 0.04 | 0.21 | 1 | 0.09 | 0.07 | 0.12 | 0 | - | - | - | 15 | 0.08 | 0.04 | 0.16 |
| Any rash | 47 | 0.35 | 0.24 | 0.50 | 6 | 0.20 | 0.06 | 0.60 | 2 | 0.06 | 0.02 | 0.21 | 55 | 0.29 | 0.21 | 0.40 |
| Generalised rash | 31 | 0.24 | 0.15 | 0.37 | 6 | 0.20 | 0.06 | 0.60 | 2 | 0.06 | 0.02 | 0.21 | 39 | 0.21 | 0.14 | 0.32 |
| Rash | 16 | 0.12 | 0.08 | 0.16 | 0 | - | - | - | 0 | - | - | - | 16 | 0.08 | 0.05 | 0.13 |
| Any musculoskeletal | 331 | 2.38 | 1.89 | 3.01 | 7 | 0.12 | 0.02 | 0.67 | 15 | 0.47 | 0.23 | 0.95 | 353 | 1.81 | 1.41 | 2.32 |
| Arthropathy | 79 | 0.55 | 0.33 | 0.92 | 0 | - | - | - | 0 | - | - | - | 79 | 0.39 | 0.22 | 0.68 |
| Muscle aches/myalgia | 311 | 2.25 | 1.77 | 2.87 | 7 | 0.12 | 0.02 | 0.67 | 15 | 0.47 | 0.23 | 0.95 | 333 | 1.72 | 1.34 | 2.20 |
| Any neurological | 206 | 1.50 | 1.20 | 1.88 | 6 | 0.30 | 0.26 | 0.35 | 5 | 0.19 | 0.07 | 0.56 | 217 | 1.12 | 0.88 | 1.41 |
| Bell’s palsy | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - |
| Guillain-Barre Syndrome | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - | 0 | - | - | - |
| Headache | 192 | 1.40 | 1.12 | 1.74 | 6 | 0.30 | 0.26 | 0.35 | 5 | 0.19 | 0.07 | 0.56 | 203 | 1.05 | 0.83 | 1.32 |
| Peripheral tremor | 24 | 0.16 | 0.12 | 0.22 | 0 | - | - | - | 0 | - | - | - | 24 | 0.12 | 0.09 | 0.16 |
| Seizure/Febrile convulsions | 2 | 0.01 | 0.00 | 0.05 | 0 | - | - | - | 0 | - | - | - | 2 | 0.01 | 0.00 | 0.03 |
N: number of participants vaccinated.
n: number of participants reporting an AEI at least once.
%: percentage of participants reporting an AEI at least once estimated from logistic GEE models adjusted for clustering effect of general practices, with upper and lower limits of the 95% CI based on the robust variance estimate.
AEI: adverse event of interest; AERC: adverse event reporting card; EHR: electronic health record; EMA: European Medicines Agency; GEE: generalized estimating equation; LL: lower limit; UL: upper limit; 95% CI: 95% confidence interval.