Table 1.

Diagnostic criteria for suspected adverse effects after human papilloma virus (HPV) vaccination

I. Prerequisite

1. At least one exposure to HPV vaccination

2. No abnormality of a physical or psychological condition before HPV vaccination

3. Appearance of clinical manifestations after HPV vaccination

II. Major symptoms

1. Prolonged general fatigue (lasting for more than 4 weeks)

2. Chronic headache, especially after standing up

3. Widespread pain (migratory joint pain, limb pain, or myalgia)

4. Limb shaking (tremor or myoclonus like)

5. Dysautonomic symptoms (orthostatic fainting, postural orthostatic tachycardia, or delayed or rapid gastrointestinal motility)

6. Motor dysfunction (frequent sudden falls, limb weakness or paralysis, gait disturbance)

7. Abnormal sensation (coldness in limbs, limb paresthesia, photophobia)

8. Sleep disturbance (hypersomnia, insomnia)

9. Learning impairment (memory impairment, difficulties in concentration, verbal dyspraxia)

10. Menstrual abnormality (amenorrhea, hypermenorrhea, irregular menstruation)

III. Objective findings

1. Persistent hypotension

2. Orthostatic hypotension or postural tachycardia on standing or tilt table test (Schellong test)

3. Decreased skin temperature

4. Peripheral plateau pattern in digital plethysmogram

5. Decreased cognitive function test

6. Decreased regional cerebral blood flow as shown in brain single-photon emission computerized tomography

IV. Exclusion

1. Abnormality in routine blood laboratory data

2. Conditions compatible with diagnostic criteria of other diseases (e.g., juvenile idiopathic arthritis, epilepsy, and autism spectrum disorder)

3. HPV vaccination after 30 years of age

Definite case: more than five of ten major symptoms + more than three of six objective findings + no exclusive conditions

Probable case: more than five of ten major symptoms + no exclusive conditions