Table 4.
Serious adverse events following MenB-4C vaccine identified at Universities A and B (n = 54) categorized by MedDRA “System Organ Class” categories.A
| MedDRA “system organ class” category | n | Primary MedDRA preferred term for each participant with an SAE (n)B |
|---|---|---|
| Infections and infestations | 16 | Appendicitis (8), gastroenteritis (4), cellulitisC (1), infective pulmonary exacerbation of cystic fibrosis (1), meningitis viral (1), pneumonia (1) |
| Psychiatric disorders | 13 | Suicidal ideation (6), depression (2), substance-induced psychotic disorder (2), bipolar disorder (1), panic attack (1), suicide attempt (1) |
| Injury, poisoning, and procedural complications | 6 | Limb fractureD (4), alcohol poisoning (1), stab wound (1) |
| Gastrointestinal disorders | 5 | Abdominal pain (2), gastritis (1), gastrointestinal hemorrhage (1), small intestinal obstruction (1) |
| General disorders and administration site conditions | 5 | Pyrexia (4), drowning (1) |
| Musculoskeletal and connective tissue disorders | 3 | Rhabdomyolysis (2), hip deformity (1) |
| Immune system disorders | 1 | Anaphylactic reaction (1) |
| Nervous system disorders | 1 | SeizureE (1) |
| Renal and urinary disorders | 1 | Renal failureF (1) |
| Reproductive system and breast disorders | 1 | Ovarian cyst (1) |
| Respiratory, thoracic, and mediastinal disorders | 1 | Pulmonary embolismG (1) |
| Surgical and medical procedures | 1 | Jaw operationH (1) |
Note.
These serious adverse events (SAEs) occurred following vaccination, but were not necessarily caused by the vaccine. See the text for details on causality assessment of SAEs.
Additional clarifying details about certain cases are provided in the footnotes.
The cellulitis was on the knee.
All 4 cases of bone fracture were due to accidental injuries.
This was the participant’s first-ever known seizure, which occurred following dose 1 on postvaccination day 22.
Due to congenital renal hypoplasia.
Diagnosed following onset of dyspnea on postvaccination day 8 in a female participant taking oral contraceptive pills.
This surgery was performed for a condition that was known to exist prior to vaccination.