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. 2021 Aug 26;18(1):1–6. doi: 10.1080/21645515.2021.1963171

Table 1.

Number and reporting rate of symptoms/clinical signs most frequently notified in spontaneous 4cMen B vaccine AEFI-reports. Puglia Region (Italy), 2014–2019

Symptom/clinical sign n Reporting rate
(× 100.000 dosses)
Injection site reactions (redness, skin rash, swelling,
local pain)
138 17.0
Fever, hyperpyrexia 94 12.9
Neurological symptoms 74 8.8
  • Hypotonic-hyporesponsive episode

11 1.4
  • Agitation, nervousness

20 2.5
  • Sleep disorders

12 1,5
  • Fatigue, weakness, headache

22 2.7
  • Seizure, clonus, dyskinesia

7 0.9
  • Excessive, inconsolable crying

13 1.6
  • Dizziness, lipothymia

3 0.4
Gastrointestinal diseases 31 3,8
Allergic reaction 6 0.9
Lymphadenitis 2 0.3
Other local signs/symptoms 50 7.7