Table 5.
Adverse events of special interest (AESIs) reported within the 181-day postvaccination period (N=9143)
| AESIs* | n (%) | SIR (95% CI) |
|---|---|---|
| At least one AESI | 14 (0.15) | |
| Convulsions | 8 (0.09) | 2.65 (1.14 to 5.22) |
| Non-febrile convulsions | 7 (0.08) | |
| Febrile convulsion | 1 (0.01) | |
| Bell's Palsy | 3 (0.03) | 2.70 (0.56 to 7.89) |
| Guillain-Barré syndrome | 1 (0.01) | 18.11 (0.46 to 100.89) |
| Neuritis | 1 (0.01) | 11.46 (0.29 to 63.85) |
| Demyelination | 1 (0.01) | 4.88 (0.12 to 27.17) |
*AESIs for this study were anaphylactic reaction, Bell's palsy, convulsions, demyelination, Guillain-Barré syndrome, neuritis, non-infectious encephalitis, vaccination failure, vasculitis.
95% CI, 95% confidence interval (lower limit-upper limit); n (%), number of participants reporting an event (percentage), more than one event could be reported for a participant; SIR, standardised incidence ratio.