Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Irritability, Screaming, Tenderness
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no allergies or medical conditions who in the am of Jul 11 2005 was vaccinated SC in the right thigh with a 0.5 ml second dose of varicella virus vaccine live (lot 649477/0761P). Concomitant vaccination on the same day in the other leg included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. The physician reported that after the patient was vaccinated with varicella virus vaccine live, he would not walk on or put any weight on the vaccinated leg for three weeks. He also walked with a limp for about three weeks. Unspecified medical attention was sought. No diagnostic laboratory tests were preformed. Subsequently, the patient recovered. A product quality complaint was not involved. Follow up information including medical records, was received from the physician who reported that in the am of Jul 13 2005, the patient refused to walk on his right leg for two weeks. There was induration and tenderness on the right thigh where the vaccine was given. Ice packs and acetaminophen (Tylenol) were given. On Jul 20 2005, an ultrasound of his right hip was done to rule out toxic synovitis which was negative. There was no evidence of joint fluid. The patient improved and had no limping on Jul 25 2005, at which time he was considered recovered. There were no adverse events following prior vaccination. Medical records revealed that on Aug 4 2005, a pelvis X ray was negative and a right knee X ray was normal. On Aug 5 2005, the patient was seen in a clinic by a nurse practitioner and a physician for evaluation of the injury to his right knee sustained when her received his immunization. The mother believed that it was due to the varicella virus vaccine live. The mother relayed the history of the event and indicated that for one week after the vaccine, the patient refused to walk, then he began to walk, but was left with a bit of a limp. She also felt the patients leg muscle mass seemed to be smaller on that side. Currently, the patient was walking. She had taken the patient to the ER on Aug 4 2005 for examination as she was worried about him having episodes of the knee locking and having vigorous screaming and crying episodes that lasted about a half hour. She had been giving her son ibuprofen and acetaminophen Tylenol around the clock which had been helping to a great degree as he would actually walk and play on the knee. If she did not give it to him, he seemed awfully fussy. On physical exam by the nurse practitioner on Aug 5 2005, the patient was a healthy appearing 15 month old child in no distress. He was sitting in a crouched position, like a baseball catcher. He stood up and sat down and sat on his knee and sat crouched without difficulty or pain that was obvious. When he stood up, he did have a bit of a limp with less weight being applied on the right leg, but this was very mild. He was very playful and interactive. He did not seem in any way sick. He did not have any warmth with palpation of one knee over the other. He had excellent flexion and extension. He abducted his hips equally to 80 degrees. He had no limitation in range of motion. He stood up and crawled on the floor. X rays were reviewed and revealed no evidence of bony abnormality. Pelvis X rays were also negative. His white blood cell count was 11.6 his platelet count was normal at 350, his sedimentation rate was 10, and his CRP was less than 0.7. The impression was trauma to the right quadriceps muscle status post varicella virus vaccine live immunization. The nurse practitioner and the physician explained to the parents that they felt the patient did not have any significant injury. He had no signs of infection process. His laboratory studies and X rays were normal and his behavior in the clinic did not ever show any signs of any marked irritation in regards to the knee joint. He was very interactive and sat in all sorts of different positions that cause a lot of weight to be bearable on the knee and hip region, but had no signs of limitation or irritation. It was felt that with time, the patients muscle atrophy would resolve as the patient became more active and beared more weight. It was not felt that he had any signs of a septic joint. The mother had a difficult time believing this, as she felt that the patient was not doing very well. This was discussed at great length and the physician also examined the patient for the parents comfort. The physician agreed with the nurse practitioner's evaluation. The parents were advised to ween off the around the clock Tylenol and ibuprofen. The physician was to call the family on Aug 8 2005 to check on the patient. Would not walk/put any weight on vaccinated leg, walked with a limp, and induration and tenderness where the vaccine was given was considered to be disabling by the physician. No further information was provided.