Age: 19.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Rheumatoid arthritis, Thyroid function test
Clinical narrative: Information has been received from a nurse (patients mother) concerning her 19 year old daughter, with no concomitant medications, no drug allergies, and no pertinent medical history, who in July 2007 (date unreported), was vaccinated with the first single dose, injection, of GARDASIL (Lot # not specified).  The second single dose injection of GARDASIL, (Lot # not specified) was approximately two months later in SEP-2007, (date unreported), and the third single dose injection of GARDASIL, (Lot # not specified) was in DEC-2007; (date unreported).  One week following the third dose of GARDASIL the patient initially complained of pain in both knees and then subsequently she had pain in her hands.  She also experienced shortness of breath.  The patient sought unspecified medical attention and had blood tests, thyroid studies and x-rays (no dates, test names or results were reported).  Subsequently, she was diagnosed with rheumatoid arthritis.  As of the date of the report 12-MAY-2008, the patient has not recovered.  No product quality complaint was involved.  Additional information has been requested.  7/4/08 Reviewed rheumatology office notes of 5/1/08-5/19/2008 FINAL DX: rheumatoid arthritis Records reveal patient experienced scaly erythematous rash on dorsum of feet 9/2007 followed by joint pain & swelling.  Joint pain persistent daily & worse in AM.  Had been tx in 3/2008 w/tapering steroids w/dramatic improvement.  NSAIDS not helpful. On exam, had decreased grip strength bilaterally.  8/5/08 Reviewed PCP medical records & vax records.   VAX: 5/24/2007: HPV #1, 0389U, IM, LA                          Hep B #1, 0039U, IM RA         7/27/07:    HPV #2, 0802U, IM RA                         Hep B #2, 0007U, IM LA                         Menactra, U2367AA, IM LA         12/26/07:  HPV #3, 1267U, IM LA                         Hep B #3, 0874U, IM LA                         Adacel, C904AA, IM RA Records reveal patient c/o stiff hands in AM on 5/24/07 visit & had just started acne meds.  8/5/08 Reviewed urgent care medical records of 2/29/2008 which included labs already received from rheumatologist. FINAL DX: arthritis Records reveal patient c/o of joint pain, swelling, decreased energy since 12/2007. Patient noted to have s/s thyrotoxicosis, throat erythema.  Tx w/IM steroids & NSAIDS.  D/C to home. This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a physician and a nurse consumer concerning her 19 year old daughter with no known drug allergies and a history of knee pain due to patellar subluxation (since age 15) and without a family history of arthritis. In July 2007 the patient was vaccinated with a first dose of GARDASIL (Lot # not reported). There were no concomitant medications. In approximately September 2007, two months later, the patient was vaccinated with a second dose of GARDASIL (Lot # not specified) and developed a scaly rash on the dorsum of her feet. In December 2007, the patient was vaccinated with a third dose injection of GARDASIL (Lot # not reported). One week following the third dose she complained of pain in both knee. Subsequently she had pain in her hands. This was followed by pain in the wrists, temporomandibular joints, shoulders, elbows, all the small joints of her hands (worse in the metacarpophalangeal joints) ankles and feet. Swelling occurred in the wrists, MCP joint of the hands, left knee and ankles. She had persisted join pain daily. Morning stiffness was "all over" and lasted all day. She also experienced shortness of breath. Subsequently, the patient was seen at a university hospital and it was thought she had "tendenitis of her left wrist and arthritis." Laboratory tests of February 2007 revealed as sedimentation rate of 27. On 29-SEP-2008 a Heterophile Mean Hernia was negative and Lyme Disease AB serology was negative. In March 2007 she was treated with a MEDROL DOSE PACK which gave her dramatic relief for a few days and NAPROSYN 500 mg bid which did not help. She also took ibuprofen on a prn basis. On 17-APR-2008 the patient had a chest X-ray which showed no significant abnormality. On 01-MAY-2008, the patient was been by rheumatology and physical examination was normal except for the scaly erythematous rash on the dorsum of her feet. There was slight synovial thickening of the wrists as well as the 2nd and 3rd MCP joints bilaterally. Tenderness was noted in the metacarpophalangeal (MIP) joints bilaterally. Grip strength was decreased. Laboratory studies done were as follows: Cyclic Citrullinated Peptide CCP antibodies. ICC was strongly positive at 200. C-reactive protein was slightly elevated at 1.2. Urinalysis was reported as normal (with 30-40/epithelial cells trace mucus and bacteria). Rheumatoid factor was positive at 59.9. It was reported that she had rheumatoid arthritis based on her history of a symmetrical polyarticular disease, prolonged morning stiffness, physical findings and strongly positive serologies but the rheumatologist wanted to follow the patient for a longer period of time before determining a definite diagnosis. The patient was told to discontinue both ibuprofen and NAPROSYN. On approximately 09-MAY-2008, the patient was treated with TRILISATE 750 mg bid. Further recommendations for treatment included a consultation and disease modifying anti-rheumatic drug or drugs and a dermatology consult for her feet. At the time of the report the patient had not recovered from the rheumatoid arthritis, shortness of breath and the scaly rash on the dorsum of her feet. The outcome of the tendinitis of the left wrist was unknown. No product quality complaint was involved. Additional information has been requested.