Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin lesion, Skin mass, Streptococcus test negative, Tendonitis, Thyroxine normal
Clinical narrative: This spontaneous report was received on 15-DEC-2016 from a Licensed Practical Nurse (LPN) via a Vaccine Adverse Event Report Form and medical records concerning a 16 year old female patient (pt) (weight 106 pounds; height 62.25 inches) who on and unspecified date, received dose one of GARDASIL (route and lot # not provided). In 2015, she received dose two of GARDASIL (route and lot # not provided). On 17-AUG-2016 received her third dose with GARDASIL 9 intramuscularly in the left arm (lot # L000610). Concomitant medication included ORTHO TRI-CYCLEN for dysmenorrhea, irregular menstrual cycles and also for birth control as she was sexually active. The LPN reported that the pt had no symptoms after the first vaccination. After the second vaccination, she experienced mild joint pain, fatigue and weight loss. After her third vaccination with GARDASIL 9, on 26-SEP-2016, the pt experienced bilateral ankle swelling, joint pain, dizziness, fatigue and "abnormal labs) (LPN noted see attached). The pt had not recovered from the events at the time of the report. Medical records revealed the following: The pt had no known drug allergies. On 17-AUG-2016, she received GARDASIL 9 at her pediatrician's office (administered by a Medical Assistant). On 02-SEP-2016, the pt's mother called the pediatrician's office and discussed possible lymph node swelling. Was told if still present to schedule an appointment. On 26-SEP-2016, the pt saw her pediatrician with chief complaint of possible side effects from GARDASIL 9. The pt complained of fever, dizziness and sore throat. During review of systems, the pt admitted to joint pain and lightheadedness. Physical exam revealed erythema present in oropharynx, tonsils appeared normal. There were a bilateral thigh erythematous maculopapular lesions present. At the office, the following were negative: urine dip, mononucleosis test, rapid stress test and throat culture (also noted that overnight culture was to be sent). Complete blood count revealed the following abnormalities: monocytes 18.3 %, monocytes 1.2 cells/uL, mean cell hemoglobin concentration 32.2 g/dL, red cell distribution width 13.8% and mean platelet volume 7.3 fL. Assessment was fever, acute pharyngitis and joint pain. Additional labs were ordered. She was prescribed naproxen. On 28-SEP-2016, results from throat culture revealed that adenovirus, mycoplasma pneumoniae, group A streptococcus, human coronavirus and enterovirus were negative. Bordetella pertussis was positive. On 30-SEP-2016, a comprehensive metabolic panel revealed the following abnormalities: calcium low 8.6 mg/dl and albumin low 3.4 g/dl. Thyroid stimulating hormone and T4 were normal. Complete blood count with differentials and platelets revealed the following abnormalities: red blood cell count low 3.78 million/uL, hemoglobin low 10.4 g/dL, hematocrit low 31.7 %, absolute neutrophils high 8008 cells/uL and absolute lymphocytes low 810 cells/uL. C-reactive protein was high at 3.73 mg/dL. Epstein-Barr antibody was negative. On 01-OCT-2016, nasopharyngeal aspirate was negative for bordetella pertussis. On 04-OCT-2016, sedimentation rate by Modified Westergren was high at 65 mm/hr. Rapid plasma reagin was non-reactive. Antinuclear antibody (ANA) screen IFA was positive. ANA pattern was homogenous. ANA titer was high at 1:80. Chlamydia and Neisseria gonorrhea were negative. On 19-OCT-2016, the pt saw a Rheumatologist. He last saw the pt on 19-MAY-2015 at which time the pt was doing well with regard to enthesis and tendinitis on MOBIC. At that time, she had onset of musculoskeletal pain about 2-3 weeks after she received a second GARDASIL. Her chief complaint at the 19-OCT-2016 was of more severe musculoskeletal pain which had onset about four weeks after her third GARDASIL 9 vaccination. She also had a fever nightly of about 101 degrees and an erythematous rash on her lateral thighs and subcutaneous nodules on her lower extremities. The mother stated that lab tests were positive for pertussis and the pt was started on ZITHROMAX, which resolved the fever and the rash. She was taking NAPROSYN without benefit for her musculoskeletal pain. The pt stated that she did have swelling of her proximal interphalangeal joints and her musculoskeletal pain was generalized. He had discussed the case with the pt's pediatrician and she was started on prednisone 10 mg daily and had immediate marked improvement with her musculoskeletal symptoms. The pt stated she was doing great and for perhaps five minutes in the morning she was stiff. The mother stated she was stiff for more like 15 to 20 minutes in the morning. She took prednisone 10 mg daily for a week and at the time of the visit, had been on 7.5 mg daily in the mornings for about 16 days. She had been attending school. She was taking no other medications besides birth control pills. Physical exam revealed weight 102 pounds. She had what appeared to be a staph skin lesion inside her nasal cavity that had been sore the past few days. She also had a faded erythematous rash on her left thigh which was barely visible. Her joints were without swelling or tenderness and had full range of motion. Her mood was good. Impression and recommendations: The pt had reactive arthritis as well as a rash, fever and subcutaneous nodules, all of which improved on low dose prednisone. This occurred temporally associated with the GARDASIL vaccine. She had problems with musculoskeletal symptoms to a lesser degree after receiving a second GARDASIL in 2015. The Rheumatologist was optimistic that the symptoms would resolve with time. She was to continue prednisone 7.5 mg daily for a total of four weeks to be followed by 5 mg each morning for two weeks, then 2.5 mg each morning for two weeks, then stop. She would have labs again in three weeks and follow-up visit in four weeks. She was prescribed BACTROBAN for her nose sore. On 03-NOV-2016, the pt saw the Rheumatologist for follow-up. He noted again that the pt had reactive arthritis with rash and nodules precipitated by her third dose of GARDASIL 9 vaccine. He prescribed prednisone 7.5 mg daily with instructions for tapering at her last visit. The rheumatologist stated that the pt had not followed his instructions. She had been often taking 10 mg for malaise and musculoskeletal pain. She had had no fever or subcutaneous nodules. She had not had a rash. The pt stated that if she sat still for a while, her joints felt tight and stiff. Some days, she felt more tired than others. Physical exam: All joints were without swelling and had full range of motion. She had mild tenderness over the fifth metacarpophalangeal joint and bilateral second through the fourth proximal interphalangeal joints. Impression and recommendations: The symptoms of reactive arthritis, rash, fever and subcutaneous nodules temporally associated with the third GARDASIL 9 vaccine had resolved. She had, however, fibromyalgia symptoms persisting. The Rheumatologist again gave her instructions for prednisone tapering. She could also take ALEVE as needed. If she was more difficult to manage, may consider trial of NEURONTIN. Labs were ordered. On 16-NOV-2016, the pt saw the Rheumatologist for follow-up. At that point, she was on prednisone 8 mg daily. The pt stated she had no fever, joint swelling, joint stiffness or pain, or nodules. She continued to have fatigue. She had been routinely attending school. She had not needed to take any medications except low dose prednisone. She was taking a multivitamin with iron. It was noted the pt has had an adverse reaction to GARDASIL on two occasions. Labs from 14-NOV-2016 included C4 level 35, sedimentation rate 27, C-reactive protein 6.2 mg/dL, hematocrit 34%, CCP antibody not detected and a negative rheumatoid factor. Impression and recommendations: The pt had persisting fibromyalgia symptoms which improved except for fatigue. The Rheumatologist recommended continuing tapering prednisone as prescribed. He also prescribed elemental iron 65 mg daily. She would have labs collected prior to another visit with him in five weeks. On 02-DEC-2016, the pt's mother called the pediatrician because she was very concerned about the pt's ongoing joint pain. The mother was convinced the symptoms were related to GARDASIL. The pediatrician discussed their previous conversation (date unspecified) where the mother and the pt told the pediatrician that they had figured out the symptoms were due to the pt's acne medication (not specified). The pt had even told the pediatrician during that visit (prior to receiving the third GARDASIL 9 vaccine) that she realized all symptoms stopped when she stopped the acne medication. She was symptom free for some period of time. To test it, she restarted the acne medication and the symptoms came back. Being convinced it was the acne medication, she discontinued it again and all the symptoms stopped. All symptoms were resolved for many months prior to her coming for the third GARDASIL 9. The pediatrician had this discussion prior to giving the pt her third vaccine dose. The mother told the pediatrician she recalled that discussion, but now was saying she was really never convinced that it was the acne medication. The pediatrician discussed with the mother that she would speak to the Rheumatologist to get further direction on treatment and management. The pediatrician then spoke to this Rheumatologist who stated he could not rule out the possibility of GARDASIL as the cause of the pt's symptoms. He stated he would call the mother and adjust steroid dosing over the weekend. Plan was to get blood work that day and see her on 05-DEC-2016. The pediatrician then called the mother after she spoke to the Rheumatologist. The mother stated she did hear from the physician's office regarding blood work and appointment. The pediatrician offered a genetics referral but the mother preferred to wait for now. The pediatrician gave the mother information on the National Vaccine Compensation Fund. The LPN reported that the bilateral ankle swelling and joint pain (after GARDASIL 9) (considered symptom of reactive arthritis), dizziness and fatigue (considered symptom of fibromyalgia) resulted in persistent or significant disability/incapacity. Upon internal review, pertussis was considered medically significant. All available medical records will be provided upon request. Additional information has been requested.