Table 1.

MedDRA terms used to identify potential unrecognised CRPS cases in the safety database.

Proposed clinical diagnostic criteria for CRPS (Budapest criteria)(Harden et al., 2010)⁎	MedDRA Preferred terms or low level terms
Pain: continuing pain disproportionate to vaccination	Pain; pain in extremity
Sensory: allodynia deep pressure pain, allodynia pain after movement, allodynia after light touch, hyperesthesia, hypoesthesia, hyperalgesia, hypoalgesia	Allodynia, hyperaesthesia, hypoaesthesia, sensory disturbance, skin burning sensation
Vasomotor: color change/difference, temperature difference	Skin discoloration, temperature difference of extremities
Sudomotor/edema: transpiration disturbance, edema	Oedema
Trophic: hair growth change, nail growth change, trophic skin disturbance	Hair growth abnormal, nail growth abnormal
Motor: limitation of movement, limitation of strength, dystonia, tremor, bradykinesia	Injection site movement impairment, injected limb mobility decreased, muscular weakness, dystonia, tremor, bradykinesia

^⁎Pain should be continuous and disproportionate to the inciting event. In addition, for clinical diagnosis patients should have at least one symptom in each of the above categories and one sign in one category.