Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Autoimmune disorder, Back pain, Blindness, Borrelia burgdorferi serology negative
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history reported and no known drug allergies who in May 2007, was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. Sometime after receiving the first dose, the patient started complaining of joint pain of knees and back, fatigue and tiredness. Then, the patient received her second dose of GARDASIL (dose, route and lot number not reported) and in November 2007, she received her third dose of GARDASIL (dose, route and lot number not reported). A few weeks after receiving the first dose, the patient developed a full brown uveitis. The patient was given steroids (name and manufacturer unspecified) which she had a reaction to and now, the patient was legally blind, but she had some outpatient eye surgeries and developed glaucoma. The patient was taken to a Hospital to see a physician and they did blood work and X-rays of her knees and back (results not provided) and the patient was diagnosed with autoimmune disease. The patient's mother reported that the patient was put on infliximab (manufacturer unknown) and which did not help, and now was on HUMIRA which was helping her joint pain. The patient's joint pain on knees and back, fatigue and tiredness, full blown uveitis, legally blind, outpatient eye surgeries, glaucoma and autoimmune disease persisted. Follow up information was received from a registered nurse. She stated that the patient received the GARDASIL vaccinations on the following dates: the first dose was given on 03-MAY-2007 (Lot number 656051/0244U, route not reported), the second dose was given on 10-JUL-2007 (Lot number 657621/0387U, route not reported) and third dose was given on 15-NOV-2007 (Lot number 658560/1062U, route not reported). There were no concomitant vaccinations administered at the time the GARDASIL vaccinations were administered. The Registered nurse stated that there was no documentation that the patient had any reaction to the GARDASIL vaccination between the 03-MAY-2007 to 15-NOV-2007. She stated that on 10-DEC-2007, the physician was notified that the patient had possible "pink eye". The patient was treated with eye drops (name of drops unspecified). On 11-DEC-2007, the patient complained of eye sensitivity. The patient's eye drops were changed. The patient was tested for Lyme's disease. On 18-DEC-2007, the patient was seen by an ophthalmologist. On 18-DEC-2007, the Lyme disease test was negative. On 27-DEC-2007, the patient's eye drops were strengthened and "prednisone drops" added to the patient's treatment. The patient complained of knee and joint pain on 27-DEC-2007. The patient was seen on 13-APR-2009, 27-APR-2009, 04-MAY-2009 and 07-MAY-2009. The patient was also referred to a rheumatologist. Upon internal review, legally blind was determined to be an other important medical event. Additional information has been requested. 10/16/09 Received medical records from Ophthalmology consultations from 12/18/07 to 7/13/09. DX: bilateral uveitis, open angled glaucoma r/t steroids. SX: Pt. presented to ophthalmologist with redness, pain in eye. Pt was tx with steroids, throughout the following visits uveitis progressed to both eyes and pressure in eyes fluctuated. 7/1/08 pt. DX with open angled glaucoma r/t steroid tx. Pt continued to be f/u, tx included steroid injections, stent placement right eye 2/08. Pt. vision stable with medication assistance. Peripheral vision continues to decrease as of last visit 7/13/09. Records received from Rheumatology consults from 5/7/09 to 8/13/09. OV 5/7/09 DX: Non applicable JIA/Juvenile Rheumatoid Arthritis. Pt presented with h/o recurrent uveitis and glaucoma. Pt. c/o joint pain in knees x2yrs, occasional back pain, occasional HA. Assessment: PE WNL. Labs ordered. Methotrexate ordered. OV 8/13/09 DX: unspecified iridocyclitis, uveitis. Pt. seen for f/u. Pt. c/o occasional eye redness, HA, depression, weight increase. Assessment: pt has no new symptoms and uveitis stable. Pt. has had referral to see psychiatry. Pt stable at this time and scheduled to f/u 3 months.