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