Table 3.
Reported Serious Adverse Event | Intervention | No. of Days from Receipt of Vaccine or Placebo to Onset of Event | Relation of Event to Intervention |
---|---|---|---|
Acute pericarditis | Live attenuated vaccine | 17 | Possibly associated |
Injuries from car accident | Live attenuated vaccine | 9 | Definitely not associated |
Mononucleosis | Inactivated vaccine | 14 | Probably not associated |
Exacerbated hypertension and cardiomyopathy | Inactivated vaccine | 17 | Probably not associated |
Repair of anterior cruciate ligament | Placebo | 33 | Definitely not associated |
Uterine myomectomy | Inactivated vaccine | 74 | Definitely not associated |
Repair of three partially amputated fingers | Inactivated vaccine | 89 | Definitely not associated |
Ovarian cyst | Inactivated vaccine | 90 | Definitely not associated |
Orchiectomy for testicular cancer | Inactivated vaccine | 91 | Definitely not associated |
Rotator cuff repair | Live attenuated vaccine | 161 | Definitely not associated |
Placebo was physiologic saline administered as either an intramuscular injection or intranasal spray. The relation of the event to the intervention was determined by the independent safety monitor for this trial.