Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Back pain, Blood culture negative, Chest pain, Electrocardiogram, Pyrexia
Clinical narrative: Initial report was received from another manufacturer on 22 April 2013 (Reference Number MC201200121). The following was taken verbatim from the reported case description: "A 49-year-old male patient was hospitalized on 16 February 2012 at 08:57 and enrolled into the study and underwent a percutaneous coronary intervention (PCI). Prior to randomization he received aspirin 81 mg, unfractionated heparin (UFH) and bivalirudin. On 16 February 2012 at 10:54, an angiography revealed one vessel with greater than 50% stenosis. At 11:17 the patient received a loading dose of four capsules of blinded study medication. At 11:20, the patient received a 10.3 ml bolus of blinded study medication, followed by an 82.2 ml/hour infusion of blinded study medication from 11:21 to 13:30. At 11:20, the patient began to undergo a PCI via a radial catheter access site during which time the right coronary artery (RCA) was treated with three non-drug eluting stents (total length of 71). The patient received four capsules of blinded study medication post infusion at 13:30. Post procedure, he was given clopidogrel 75 mg. At discharge, he received Aspirin and clopidogrel 75 mg. On 17 February 2012 at 9:22, the patient received the influenza virus immunization and pneumococcal 23 immunization. The patient was discharged from the hospital on 17 February 2012 at 10:55. The patient returned to the hospital via the emergency room on 17 February 2012 at 18:59 with complaints of back pain, chest pain, and a fever of 103 degrees Fahrenheit. The patient was admitted to the hospital and diagnosed with possible drug fever at 21:05. Blood cultures obtained on 17 February 2012 were negative. An electrocardiogram (EKG) was obtained; however the results were not provided. Treatment included intravenous (IV) vancomycin and IV LEVAQUIN. On 20 February 2012, the patient was discharged form with oral LEVAQUIN (five days of treatment). The events resolved on 20 February 2012 at 11:18. The study drug dose was not changed due to the event. Medical history included diabetes (type 2), former smoker, hypertension, and hyperlipidemia. Concomitant medications included Aspirin, bivalirudin, unfractionated heparin, clopidogrel, hydrochlorothiazide, oxycodone HCL/acetaminophen, fosinopril sodium, simvastatin, and gabapentin. Co-suspect medications included the influenza virus immunization and pneumococcal 23 immunization (also reported as suspect product pneumococcal vaccine). The investigator considered the event of "possible drug fever" to be possibly related to blinded study medication, the influenza virus immunization and pneumococcal 23 immunization. Additional information received on 13 April 2012 was incorporated into the above narrative: specific antibiotic treatment that was rendered for the event; and addition of co-suspect medications influenza virus and pneumococcal 23. Case Comment: The patient was diagnosed with possible drug fever approximately 31 hours and 30 minutes after the last dose of the blinded study medication. The investigator considered the event of "possible drug fever" to be possibly related to the study medication. Additional information received on 13 April 2012 does not change the case causality assessment. Additionally, the investigator considered the influenza virus immunization and pneumococcal 23 immunization as co-suspect medications. This case was unblinded to clopidogrel." Relevant tests included: Angioigram on 16 February 2012 (one vessel with >50% stenosis), blood culture (negative) and body temperature of 103 degrees Fahrenheit on 17 February 2012, and electrocardiogram (results not provided). The patient's outcome was recovered on 20 February 2012. Documents held by sender: none.