Table 5.
Serious adverse events reported spontaneously and their potential relationship with the immunization.
| Study period | 2009/2010 inflenza pandemic | 2014/2015 influenza season | ||
|---|---|---|---|---|
| Type of SAE | Number of cases | Causal relationship | Number of cases | Causal relationship |
| Guillain–Barré Syndrome | 1 | Absent (Hodgkin’s disease) | 1 | Possible |
| Sweet’s syndrome | 1 | Possible | ||
| Hemiparesis | 3 | Absent (stroke) | ||
| Limb paresis | 3 | Possible | ||
| Seizures | 2 | Absent (epilepsy) | ||
| Thrombocytopenic purpura | 1 | Possible | ||
| Hyperglycaemia | 1 | Unlikely (diabetes) | ||
| Gastrointestinal disorders | 2 | Possible | ||
| Acute arteritis | 1 | Unlikely | ||
| Vaso-vagal syncope | 2 | Possible | ||
| Fatal acute abdominal disorder | 2 | Absent | ||
| Asthma attack | 2 | Possible | ||
| Total SAE | 21 | 1 | ||
| No. of vaccinated subjects | 705,883 | 65,018 | ||
| SAE notification rate (*) (/10,000 subjects) | 0.3 | 0.2 | ||
| 95% CI (/10,000 subjects) | 0.2–0.4 | 0.0–0.5 | ||
SAE, serious adverse events.
(*) The difference between the 2 SAE rates is not statistically significant (Fisher’s exact test).