Table 3.
Primary Adverse Events Among Serious MenB-FHbp Reports (n = 44)a
| Primary System/Organ/Class | No. | Preferred Term for Primary Diagnosis or Symptom Reported, No. |
|---|---|---|
| Blood and lymphatic system disorders | 2 | Leukocytosis (1), leukopenia and thrombocytopenia (1) |
| Gastrointestinal disorders | 1 | Volvulus of bowel (1) |
| General disorders and administration site conditions | 16 | Asthenia (1), chest pain (1), chills (1), malaise (1), pyrexia (11), swelling (1) |
| Immune system disorders | 1 | Hypersensitivity (1) |
| Infections and infestations | 3 | Cellulitisb (1), meningitis aseptic (1), pneumonia (1) |
| Nervous system disorders | 15 | Guillain-Barre syndrome (2c), headache (8), seizure (2), syncope (3) |
| Psychiatric disorders | 3 | Conversion disorder (1), psychogenic seizure (1), psychotic behavior (1) |
| Renal and urinary disorders | 1 | Nephritis (1) |
| Vascular disorders | 2 | Shockd (2) |
Abbreviation: MenB-FHbp, Bivalent Meningococcal Group B Vaccine.
aThe primary diagnosis or symptom reported as an adverse event was determined by manual review.
bThe cellulitis was at the injection site of another vaccine; MenB-FHbp was not given in the same limb.
cThese 2 reports were submitted by different reporters and appear to be about the same person, but there was insufficient information reported to definitively consolidate them into a single record.
dNo etiology was identified in either case of shock.