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. Author manuscript; available in PMC: 2019 May 4.
Published in final edited form as: Vaccine. 2015 Oct 27;33(48):6684–6688. doi: 10.1016/j.vaccine.2015.10.084

Table 2.

Diagnostic categories for the 309 reports of adverse events after Flucelvax® (ccIIV3) in VAERS among persons vaccinated July 1, 2013 through March 31, 2015 (reports received by April 30, 2015)

MedDRA System Organ Class N (%)
General disorders and administration site conditions 152 (49.2)
  Local reactionsa 74
Immune system disorders 73 (23.6)
  Anaphylaxisb 2
Musculoskeletal and connective tissue disorders 35 (11.9)
Nervous system disorders 14 (4.5)
  Guillain-Barré syndromec 4
  Bell’s palsy 2
Respiratory, thoracic and mediastinal disorders 11 (3.6)
Gastrointestinal disorders 5 (1.6)
Cardiac disorders 5 (1.6)
Skin and subcutaneous tissue disorders 3 (1.0)
Infections and infestations 3 (1.0)
Ear and labyrinth disorders 2 (0.6)
Otherd 4 (1.3)
a

Local reactions comprised 48.7% of adverse events in this group

b

One report met Brighton criteria for level 2, and one that did not meet Brighton criteria but was physician diagnosed

c

One report met Brighton criteria level (BL) 1, one BL 2, one BL 3, and one was not verified as a GBS case

d

Other includes one report each of endocrine disorder, psychiatric disorder, an unspecified adverse event, and a death due to cardiovascular disease secondary to diabetes