Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Laboratory test abnormal, Pyrexia, Rheumatoid arthritis
Clinical narrative: Information has been received from a RN concerning a 11 year old female with no past medical history and no known allergies who on 14-SEP-2001 was vaccinated with the first dose of Recombivax HB. The child received the adult formulation as a part of the adolescent dosing regimen. It was reported that one week following the vaccination the child developed a fever and chills. The child also experienced pain in her left wrist, knee and ankle and experienced chest pain. In addition, the child developed a rash which was described as urticaria. The child was seen by her pediatrician who performed blood work. The rheumatoid factor was negative. The child was referred to a rheumatologist and was diagnosed with rheumatoid arthritis. At the time of this report the rash persisted and was being treated with Benadryl. The child is also receiving prednisone and Celebrex. The outcome of the fever, chills, chest pain and rheumatoid arthritis is unknown. According to the nurse, the child's treating physician did not believe these events were the result of the Recombivax HB vaccine. Upon internal review, the event of rheumatoid arthritis was felt to be important for an other medical event. Additional information has been requested. The patient's father reported that on 09/16/01, his daughter had to stop playing basketball because she experienced pain in her wrist and knee. She developed a fever and chills and experienced pain in  her neck, back and all of her joints. She was seen in an emergency room three time for the pain she was experiencing. Subsequently, the patient's joint pain persisted. In FOLLOW-UP, the patient's mother reported that the patient was still experiencing a rash (not previously reported), fever, joint pain, chills and insomnia (not previously reported). The mother further stated that the patient's physician felt that her daughter's symptoms were not related to the Hepatitis B vaccine recombinant (yeast) and he felt that it was possible for the patient to experience more than one side effect at a time. The mother stated that she felt that the patient's syndrome were too much of a "coincidence" not to be related to the Hepatitis B vaccine recombinant (yeast). FOLLOW-UP information has been received from a registered nurse. The nurse reported that the child received the adult formulation of the vaccine as part of the adolescent dosing regimen. It was reported that within one week following the vaccination the child developed a fever (temperature measurement not provided) and chills. The child also experienced pain in her wrists, elbow, knees and ankle, and experienced  chest pain. In addition, the child developed a rash which was described as urticaria. The child was seen by her pediatrician who performed blood work. The rheumatoid factor was negative. The child was referred to a rheumatologist  and was diagnosed with rheumatoid arthritis. At the time of this report, the rash persisted and was being treated with diphenhydramine (Benadryl). The child is also receiving Prednisone and Celecoxib (Celebrex), was reported to be doing better. According to the nurse, the child's treating physicians did not believe that these events were the result of the Hepatitis B vaccine recombinant (yeast). Upon internal review, the event of rheumatoid arthritis was felt to be important  for an other medical event. Conflicting FOLLOW-UP revealed that the onset of the patient's fever, rash, and joint soreness was on 09/21/01. FOLLOW-UP information from a nurse practitioner indicated that the patient developed juvenile rheumatoid arthritis one month after receiving Hepatitis B vaccine recombinant (yeast). The family thinks the patient may have received MMR instead of Hepatitis B vaccine recombinant (yeast). Additional follow up information received from the nurse practitioner indicated that the patient was in her office's care for a chronic rheumatic disease and that her office didn't feel that the sutiation was a result of the immunization. they do not believe that the patient's disease was a result of an adverse event from the hepatitis B vaccine recombinant (yeast). For this reason, and the fact that they did not give the immunization originally, they have nothing to add to the case. Upon internal reveiw, the event of rheumatoid arthritis was felt to be import for an other medical evetn. Additional information has been requested. Additional information is not expected. (OMIC)  A 15-day follow up report received 9/24/2003 adds no new info.