Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Laboratory test abnormal, Muscular weakness, Myalgia, Neck pain, Sleep disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old white female with no past medical history and no known drug allergies, who on 1/29/02 was vaccinated with the third dose (suspected to be 5mcg) of hep B vaccine recombinant (lot not given). Shortly after vaccination the pt developed stomach cramps, chills, neck pain, shoulder pain, knee pain, and ankle pain. Unspecified medical attention was sought and the pt was treated with Aleve as needed for pain. All symptoms have resolved except for her shoulder, knee and ankle pain. Follow-up info was received on 9/17/02. The pt had a history of joint pain and muscle pain with weakness. Her lower extremities were more involved than the inner extremities, at the time of report. She had missed "significant amounts" of school since September. Medical records indicated that the pt was evaluated at a rheumatology clinic on 4/24/02. According to the evaluating physician, two days post-vaccination, the pt developed severe joint pain "to the point she was unable to move or get out of bed." This involved the majority of the large joints. In addition, she had muscle pain and weakness. As of the day of examination, the pt had missed 14 days of school since February and was not sleeping due to her symptoms. Her knees and ankles felt swollen, but her mother did not feel that they appeared swollen. History and physical examination revealed the following: well-appearing, healthy girl in no acute distress; complaints of fatigue and weakness; complaints of feeling "something was in her eye"; difficulty falling asleep and staying asleep; morning stiffness "all day" that involves the muscles and joints; BP 112/62. It was noted that she was sleeping 3-4 hrs at night "which is not adequate." Exercise was described as adequate and it was documented that the pt participated in physical education at school. She had been taking Naprosyn 375mg BID since late March, which had been "somewhat beneficial." The pt stated that this helped a lot. In addition, she had been taking ibuprofen 3 tablets Q6H PRN, which "had not been particularly beneficial." Lab testing performed prior to referral revealed the following: HGB/HCT, glucose, BUN, creatinine, liver enzynes, and thyroid studies normal; urinalysis "clear"; mono spot, CRP, rheumatoid factor and antinuclear antibody negative; ESR 5; uric acid 4.1. Lab samples obtained at the clinic visit 4/24/02 revealed: anti DNAse-B (<1:60) and HLA-B 27 negative. In addition, urinalysis revealed SG 1.023, pH 5.5, (dipstick) small blood, (microscopic) WBC 1, RBC 1-3, and epi 4-6. The physician's impression was that the pt had arthralgia. He also documented that he doubted hep B vaccine was the etiology for "an ongoing process such as this." Treatment with Relafen 500mg BID was recommended. In addition, the pt would be seen for follow-up in 3 months to review her course and determine if there is a change in her symptoms or presentation. At the time of report, the pt had not recovered. Upon internal review, severe joint pain, "morning stiffness that involves the joints and muscles," "unable to move or get out of bed," muscle pain, muscle weakness, "knees and ankles felt swollen," "difficulty falling asleep and staying asleep," and generalized body pain were determined to be other important medical events. Fatigue and "feeling of something in her eye" were considered to be incidental findings. Additional info has been requested.