Table 2.
Most frequently reported MedDRA Preferred Terms (PTs) in U.S. MenB-4C reports received by the Vaccine Adverse Event Reporting System (VAERS) from January 23, 2015 through December 31, 2018.
| n(%) | Reporting rate (all)£ | ||||
|---|---|---|---|---|---|
| All | Non-serious | Serious non-fatal¥ | MenB-4C only | ||
| Total reports | 1,867 (100) | 1,785 (100) | 80 (100) | 1,122 (100) | - |
| MedDRA Preferred Termc | |||||
| Injection site pain | 414 (22) | 406 (23) | 8 (10) | 286 (25) | 74 |
| Pyrexia | 306 (16) | 279 (16) | 27 (34) | 199 (18) | 54 |
| Headache | 297 (16) | 275 (15) | 21 (26) | 175 (16) | 53 |
| Injection site erythema | 276 (15) | 272 (15) | * | 177 (16) | 49 |
| Pain in extremity | 272 (15) | 261 (15) | 10 (13) | 158 (14) | 48 |
| Nausea | 257 (14) | 236 (13) | 20 (25) | 149 (13) | 46 |
| Injection site swelling | 237 (13) | 233 (13) | * | 152 (14) | 42 |
| Pain | 227 (12) | 218 (12) | 8 (10) | 151 (13) | 40 |
| Dizziness | 223 (12) | 209 (12) | 14 (18) | 106 (9) | 40 |
| Chills | 161 (9) | 146 (8) | 15 (19) | 97 (9) | 29 |
| Fatigue | 159 (9) | 149 (8) | 9 (11) | 104 (9) | 28 |
| Syncope | 136 (7) | 129 (7) | * | * | 24 |
| Erythema | 134 (7) | 132 (7) | * | 83 (7) | 24 |
| Vomiting | 132 (7) | 116 (6) | 15 (19) | 74 (7) | 23 |
| Injection site warmth | 105 (6) | 103 (6) | * | 69 (6) | 19 |
| Myalgia | * | * | * | 66 (6) | 17 |
| Asthenia | * | * | 19 (24) | * | 16 |
| Malaise | * | * | * | * | 14 |
| Hypoesthesia | * | * | 12 (15) | * | 11 |
| Paresthesia | * | * | 12 (15) | * | 14 |
| Dyspnea | * | * | 11 (14) | * | 7 |
| Gait disturbance | * | * | 11 (14) | * | 4 |
| Neck pain | * | * | 8 (10) | * | 12 |
| Vaccination complication | * | * | 8 (10) | * | 9 |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; MenB-4C, Four-component meningococcal group B vaccine
*
Adverse events not among the ten most frequently reported.
£
Reports per million doses distributed.
¥
Excludes death reports (n = 2).
c
Based on information included in initial and follow-up reports.