Table 3. Overview of the 10 most frequently spontaneously reported events for DTPa-HBV-IPV/Hib when co-administered with a PCV, worldwide and in Italy (data from post-marketing passive surveillance reports received between 23 August 2005 and 4 February 2013).
| MedDRA preferred term | Number of events | Rate per 100 000 doses of Infanrix™ hexa distributed | ||
|---|---|---|---|---|
| Total doses distributed | Worldwide n = 4102 |
Italy n = 2167 |
Worldwide n = 92 302 373 doses |
Italy n = 15 395 443 doses |
| Pyrexia | 2113 | 1337 | 2.29 | 8.68 |
| Crying | 680 | 227 | 0.74 | 1.47 |
| Hypotonia | 367 | 173 | 0.40 | 1.12 |
| Pallor | 336 | 118 | 0.36 | 0.77 |
| Vomiting | 248 | 80 | 0.27 | 0.52 |
| Urticaria | 214 | 129 | 0.23 | 0.84 |
| Erythema | 212 | 110 | 0.23 | 0.71 |
| Rash | 195 | 89 | 0.21 | 0.58 |
| Cyanosis | 185 | - | 0.20 | - |
| Convulsion | 184 | - | 0.20 | - |
| Irritability | - | 93 | - | 0.60 |
| Decreased appetite | - | 76 | - | 0.49 |
MedDR, Medical Dictionary for Regulatory Activities.