Distribution of the 10 most frequent adverse drug reactions (ADRs) in countries where HPV-16/18 vaccine has been used the longest in national immunisation programmes
| Rate per 100 000 doses distributed | ||||||
|---|---|---|---|---|---|---|
| Country | Global | UK | Netherlands | Spain | Italy | Japan |
| Total ADR reporting rate | 20.79 | 62.93 | 20.98 | 147.25 | 82.81 | |
| Event Preferred Terms | ||||||
| Injection site pain | 9.18 | 25.30 | 2.76 | 81.90 | 13.13 | |
| Pyrexia | 6.61 | 1.18 | 22.23 | 2.52 | 20.75 | 18.36 |
| Headache | 6.50 | 2.67 | 23.00 | 2.76 | 43.35 | 7.66 |
| Nausea | 4.14 | 1.66 | 18.86 | 1.20 | 11.00 | 8.35 |
| Dizziness | 3.33 | 2.52 | 15.18 | 2.64 | ||
| Injection site swelling | 2.29 | 18.90 | ||||
| Malaise* | 2.21 | 1.97 | 8.74 | 1.32 | ||
| Pallor* | 2.10 | 7.13 | 8.65 | |||
| Myalgia | 2.08 | 12.33 | ||||
| Syncope | 1.94 | 1.77 | 1.68 | 5.65 | ||
| Vomiting | 1.22 | 1.08 | ||||
| Inappropriate schedule of drug administration | 2.04 | |||||
| Abdominal pain | 8.82 | 0.96 | 6.80 | |||
| Injection site erythema† | 10.41 | |||||
| Asthenia† | 8.35 | |||||
| Injection site pruritus† | 7.83 | |||||
| Maternal exposure during pregnancy | 1.38 | |||||
| Pain in extremity | 1.65 | |||||
| Product quality issue | 1.32 | |||||
| Injection site inflammation† | 8.36 | |||||
| Pain | 7.51 | |||||
| Presyncope* | 6.80 | |||||
| Loss of consciousness* | 6.76 | |||||
| Fall* | 4.93 | |||||
| Feeling abnormal* | 4.55 | |||||
Bold text indicates recognised adverse events in the product information for Cervarix®.
*
Adverse events reported in the context of syncope.
†
Synonyms for listed events in the product label.