Table 3.

Top 10 neurological complications and HLGTs more frequently described and collected in the EudraVigilance, categorized by gender.

Neurological complications described in female patients (TOT = 2,434)	N	(%)	Neurological complication described in male patients (TOT = 3,769)	N	(%)
1. Headache	214	(8.8)	1. Myasthenia gravis	242	(6.4)
2. Myasthenia gravis	126	(5.2)	2. Headache	230	(6.1)
3. Neuropathy peripheral	104	(4.3)	3. Neuropathy peripheral	207	(5.5)
4. Dizziness	98	(4.0)	4. Dizziness	147	(3.9)
5. Seizure	76	(3.1)	5. Seizure	119	(3.1)
6. Cerebrovascular accident	62	(2.5)	6. Tremor	98	(2.6)
7. Hypoesthesia	57	(2.3)	7. Guillain–Barré syndrome	94	(2.5)
8. Somnolence	57	(2.3)	8. Cerebral hemorrhage	81	(2.1)
9. Guillain–Barré syndrome	48	(2.0)	9. Hypoesthesia	81	(2.1)
10. Cerebral infarction	47	(1.9)	10. Cerebral infarction	78	(2.1)
Reference HLGTs of neurological complications described in female patients	N	(%)	Reference HLGTs of neurological complications described in male patients	N	(%)
1. Neurological disorders NEC	808	(33.1)	1. Neurological disorders NEC	1,210	(32.1)
2. Peripheral neuropathies	249	(10.2)	2. Peripheral neuropathies	482	(12.7)
3. Central nervous system vascular disorders	238	(9.8)	3. Central nervous system vascular disorders	352	(9.3)
4. Headaches	220	(9.1)	4. Neuromuscular disorders	336	(9.0)
5. Neuromuscular disorders	179	(7.3)	5. Headaches	243	(6.4)
6. Movement disorders (incl. parkinsonism)	136	(5.6)	6. Movement disorders (incl. parkinsonism)	231	(6.1)
7. Seizures (incl. subtypes)	111	(4.6)	7. Central nervous system infections and inflammations	184	(4.8)
8. Central nervous system infections and inflammations	109	(4.5)	8. Seizures (incl. subtypes)	173	(4.6)
9. Mental impairment disorders	89	(3.6)	9. Cranial nerve disorders (excl. neoplasms)	145	(3.8)
Cranial nerve disorders (excl. neoplasms)10.	84	(3.4)	Mental impairment disorders10.	123	(3.2)

NEC, not elsewhere classified; HLGTs, High-Level Group Terms.