Table 1.
Cumulative incidence rates of AEIs within 7 days post-vaccination reported by AERC or by AERC and EHR data combined, whole study period (Weeks 35–48)a.
| AERC, N = 16,387 |
AERC+EHR, N = 16,433 |
|||
|---|---|---|---|---|
| AEIs | n | % [95%CI, LL-UL] | n | % [95%CI, LL-UL] |
| Any AEIs | 1,188 | 7.25 [5.95–8.73] | 1,514 | 9.21 [7.37–11.34] |
| Local symptoms (i.e. local erythema) | 259 | 1.58 [1.16–2.10] | 264 | 1.61 [1.20–2.11] |
| Any general nonspecific symptoms | 419 | 2.56 [1.89–3.38] | 463 | 2.82 [2.13–3.66] |
| Headache | 244 | 1.49 [1.03–2.08] | 271 | 1.65 [1.14–2.31] |
| Fatigue | 228 | 1.39 [1.02–1.85] | 249 | 1.52 [1.14–1.97] |
| <1%: Drowsiness | 106 | 0.65 [0.32–1.16] | 107 | 0.65 [0.33–1.16] |
| <1%: Fever/pyrexia | 64 | 0.39 [0.23–0.62] | 70 | 0.43 [0.25–0.67] |
| <1%: Irritability | 38 | 0.23 [0.12–0.41] | 41 | 0.25 [0.12–0.45] |
| <1%: Malaise | 1 | 0.01 [0.00–0.04] | 3 | 0.02 [0.00–0.05] |
| Any sensitivity/anaphylaxis | 62 | 0.38 [0.03–1.51] | 68 | 0.41 [0.04–1.59] |
| <1%: Rash | 46 | 0.28 [0.20–0.39] | 74 | 0.45 [0.32–0.62] |
| <1%: Anaphylactic reactions b | 42 | 0.26 [0.00–1.58] | 45 | 0.27 [0.00–1.70] |
| <1%: Hypersensitivity reactions | 16 | 0.10 [0.04–0.19] | 18 | 0.11 [0.06–0.19] |
| <1%: Facial edema | 7 | 0.04 [0.01–0.11] | 8 | 0.05 [0.02–0.11] |
| Any respiratory/miscellaneous | 638 | 3.89 [3.12–4.79] | 772 | 4.70 [3.81–5.73] |
| Rhinorrhea | 362 | 2.21 [1.57–3.01] | 366 | 2.23 [1.58–3.05] |
| Cough | 232 | 1.42 [1.06–1.85] | 318 | 1.94 [1.54–2.39] |
| Oropharyngeal pain | 203 | 1.24 [0.88–1.70] | 219 | 1.33 [0.96–1.80] |
| Coryza | 169 | 1.03 [0.80–1.30] | 172 | 1.05 [0.80–1.35] |
| <1%: Nasal congestion | 124 | 0.76 [0.53–1.04] | 139 | 0.85 [0.60–1.15] |
| <1%: Hoarseness | 99 | 0.60 [0.49–0.74] | 104 | 0.63 [0.50–0.79] |
| <1%: Wheezing | 70 | 0.43 [0.24–0.71] | 81 | 0.49 [0.30–0.77] |
| <1%: Conjunctivitis | 44 | 0.27 [0.18–0.39] | 53 | 0.32 [0.20–0.49] |
| <1%: Epistaxis | 10 | 0.06 [0.02–0.13] | 14 | 0.09 [0.04–0.17] |
| Any musculoskeletal | 400 | 2.44 [1.96–3.00] | 501 | 3.05 [2.43–3.77] |
| Muscle aches/myalgia | 353 | 2.15 [1.76–2.61] | 454 | 2.76 [2.20–3.42] |
| <1%: Arthropathy | 138 | 0.84 [0.55–1.23] | 143 | 0.87 [0.57–1.27] |
| Any gastrointestinal | 217 | 1.32 [0.99–1.73] | 248 | 1.51 [1.18–1.90] |
| <1%: Nausea | 115 | 0.70 [0.42–1.10] | 118 | 0.72 [0.42–1.14] |
| <1%: Diarrhea | 94 | 0.57 [0.44–0.73] | 112 | 0.68 [0.55–0.84] |
| <1%: Decreased appetite | 67 | 0.41 [0.27–0.60] | 73 | 0.44 [0.30–0.64] |
| <1%: Vomiting | 21 | 0.13 [0.08–0.20] | 30 | 0.18 [0.12–0.27] |
| Any neurological | 25 | 0.15 [0.08–0.26] | 28 | 0.17 [0.09–0.29] |
| <1%: Peripheral tremor | 24 | 0.15 [0.08–0.25] | 26 | 0.16 [0.08–0.28] |
| <1%: Seizure/Febrile convulsions | 1 | 0.01 [0.00–0.04] | 1 | 0.01 [0.00–0.04] |
| <1%: Bell’s palsy | 0 | 0.00 [0.00–0.02] | 1 | 0.01 [0.00–0.04] |
| <1%: Guillain-Barre Syndrome | 0 | 0.00 [0.00–0.02] | 0 | 0.00 [0.00–0.02] |
aExcludes results from GP failing to follow the protocol with respect to AERCs. Includes AERCs from two GPs systematically reporting AEI onset dates as AERC data entry dates. bThe code used to capture anaphylaxis was not specific enough so included all self-reported mild allergic reactions. No severe reactions were reported.
N: number of vaccinated subjects; n: number of subjects reporting the symptom at least once; % = (n/N)*100 = incidence rate of AEI; AEI: adverse event of interest; AERC: adverse event reporting card; EHR: electronic health record; 95% CI = 95% confidence interval (Clopper-Pearson exact CI modified for cluster data); LL = lower limit, UL = upper limit.