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. Author manuscript; available in PMC: 2009 Jan 7.
Published in final edited form as: N Engl J Med. 2006 Dec 14;355(24):2513–2522. doi: 10.1056/NEJMoa061850

Table 3.

Serious Adverse Events Reported by Participants within Approximately 6 Months after Receipt of a Vaccine or a Placebo.*

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.