Age: 14.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Gait disturbance, Immunology test abnormal, Inflammation, Joint range of motion decreased, Juvenile idiopathic arthritis
Clinical narrative: Case number PHHY2015US077235, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 574463) website on 15 Jun 2015. This report refers to a 14-year-old female patient. Her current conditions included ear infections and allergic to Sulfa Meds, supra and SEPTRA. She used to play soccer, did cheerleading and currently dances twice a week. Concomitant drug included multivitamins. She received two doses of GARDASIL (other manufacturer, batch number: not reported) on 22 Jul 2014. She was vaccinated with seasonal influenza (manufacturer and batch number: not reported) in the arm on 21 Oct 2014. On 06 Dec 2014, she woke up with a rash on her thighs, stomach, arms and back. She was taken to the doctors and they diagnosed her with Pityriasis Rosea. On the evening of 07 Dec 2014, she experienced muscle pain and could barely walk on her legs. She was taken to doctors on 08 Dec 2014 and was told that she did not have Pityriasis Rosea and that what she most likely had was a virus. Her symptoms, rash and muscle pain, continued to worsen and she was taken back to the doctors on 10 Dec 2014. It was reported that she appeared to have a viral infection and it needed to run its course. On 13 Jan 2015, she was taken to the doctors as she still had her rash, was tired all the time and still had muscle pain in her legs, arms and wrists. She also had weight loss, on 08 Dec 2014, her weight was 110 pounds on 13 Jan 2015 she was down to 99 pounds 8 ounces. Her blood was drawn and tested for NC, anti nuclear antibody, comprehensive metabolic panel, hemogram and differential, mono-test, rheumatoid factor and sedimentation rate. Results were negative for mono and a weak positive for autoimmune and sedimentation rate showed inflammation and positive for anemia. On 16 Jan 2015, she was taken to a dermatologist for a skin biopsy and results showed vasculitis. On 28 Jan 2015, she was taken to rheumatoid arthritis specialist and underwent ANCA, anti nuclear antibody, C-reactive protein, C3 Complement, C4 Complement, comprehensive metabolic panel, creatinine urine random, ferritin, hemogram and differential, proteinase 3 antibody, sedimentation rate, total protein urine random and urinalysis. She was diagnosed with undefined Juvenile Idiopathic Arthritis and prescribed her with 25 mg naproxen two times a day. As Naproxen was not working on 06 Feb 2015, prednisone was prescribed at three tablets of 10 mg of prednisone a day for one week, then two tablets for a week and then one tablet for a week. She continued to have rash and joint pain in her legs and arms. She was taking 10 mg of prednisone daily and went for x-rays on wrist and results came back good. Her range of motion was better in legs and arms, still had pain and limited range in both wrists. She received steroid injection into joint of left wrist and prednisone was reduced to 7.5 mg daily. On 01 Apr 2015, she underwent C-reactive protein, high sensitivity, food panel I IgG4, food panel II IgG, gliadin AB panel, IgA, IgG, comprehensive metabolic panel, ferritin and sedimentation rate (results: not provided). On 19 Apr 2015, she still experienced a rash on her legs, arms, stomach and back. The rash comes and goes. She still had pain in her wrists more in the right as she had the steroid injection in the left. She was unable to put pressure or support her weight on her hands. There was once again a loss of range of motion in her right arm. She cannot straighten her arm as it hurts too much. The outcome of the events reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event Juvenile Idiopathic Arthritis was upgraded based on NVS-IME list and for the events vasculitis upgraded based on the available information in the source document.