Sex: M
Vaccine: FLUX
Symptoms: Injection site cellulitis, Streptococcal infection
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of wrist pain in a male patient who received FLOLAN sterile powder for primary pulmonary hypertension. Concurrent medical conditions included primary pulmonary hypertension. On 15 May 2013 the patient started FLOLAN (intravenous infusion) at 7.52 ng/kg/min continuously (concentration 15,000 ng/ml; 1.5 mg vial strength, 92 mg/day pump rate). On June 2013, the patient experienced, "wrist pain that started about a week ago". Treatment with FLOLAN was continued. At the time of reporting, the outcome of the event was unknown. Follow-up information was received on 21 June 2013 from a healthcare professional (HCP). Current FLOLAN dosing regimen was 11.73 ng/kg/min (1.5 mg vial, 30,000 ng/mL concentration) continuously. The patient experienced a sunburn which went away everywhere on his body except for his face. The HCP considered this to be flushing. Follow-up information was received on 25 June 2013 from a nurse. The dose of FLOLAN was still 11.73 ng/kg/min at a pump rate of 46 mL/day. On an unknown date, the patient experienced hospitalization due to unknown reason and medical device complication. It was reported that the Hickman line, which originally measured 12 inches from the chest, was currently measuring 15 inches from the chest. The patient was instructed not to push it back in. The patient also reported being in the hospital (reason unknown), and the doctor wanted to replace the Hickman line. The nurse stated that she received a call from the patient with a registered nurse "for instruction on how to transfer of infusion to PIV". Treatment with FLOLAN was continued. At the time of reporting, the outcome of the events was unknown. Follow up information received from the healthcare professional (nurse) on 29 August 2013. The dose of FLOLAN was reported as 38.54 ng/kg/min continuously (concentration 60,000 ng/mL; 1.5 mg vial strength). At an unknown time in 2013 after starting FLOLAN, the patient's mother reported the patient experienced, "having shoulder pain that has gotten worse since placement of repaired Hickman last month. The patient went to local ER for evaluation of catheter". The outcome of the event shoulder pain was worse. Treatment with FLOLAN was continued. Follow-up information was received on 04 October 2013 from a nurse. Concurrent medications included ADCIRCA. It was reported that the patient began treatment with FLOLAN on 14 May 2013 (previously reported as 15 May 2013). The patient's current dose was 40.63 ng/kg/min continuously with a concentration of 60,000 ng/mL and a pump rate of 78 mL/day (vial strength 1.5 mg). On 04 October 2013, the patient was admitted to the hospital due to fevers. The nurse was informed of the hospitalization by a hospital pharmacist. Treatment with FLOLAN was continued. At the time of reporting, the outcome of the fevers was unknown. Follow-up information was received on 06 October 2013 from a nurse. Co-suspect medication included influenza vaccine unspecified. On an unknown date, the patient received influenza vaccine unspecified (details unknown). The patient's most recent dose of FLOLAN was 40.63 ng/kg/min continuously with a concentration of 60,000 ng/mL and a pump rate of 78 mL/day (vial strength 1.5 mg). The patient's mother reported that the patient received a "flu shot and has strep cellulitis at the injection site and that is the reason for admission". The "strep cellulitis at the injection site" occurred less than months after vaccination with influenza vaccine unspecified. The patient was hospitalized. At the time of reporting, no action was taken with FLOLAN and the outcome of the streptococcus and injection site cellulitis was unknown. Follow-up information was received on 07 October 2013 from a nurse. The patient's most recent dose of FLOLAN was 40.63 ng/kg/min continuously with a concentration of 60,000 ng/mL and a pump rate of 76 mL/day (vial strength 1.5 mg). The patient's mother reported to the nurse that the patient was currently hospitalized (as previously reported) and that he "got strep from the flu shot" less than months after vaccination with influenza vaccine unspecified. According to the patient's mother, the patient may be discharged on 09 October 2013. At the time of reporting, the action taken with FLOLAN and the outcome of the streptococcus was unknown.