Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, No reaction on previous exposure to drug, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old white male who was vaccinated on 18-MAY-2007 at 10:10 AM in the right arm with a second 0.5 mL SC dose of VARIVAX (lot # 656821/0174U or lot # 657192/0362U). Illness at time of vaccination included a cough, allergic rhinitis, and a enlarged lymph node. Immediately post-vaccination the patient developed hives on the chin, then neck and was sent across the street to the emergency room of the hospital. The patient was treated with BENADRYL and ORAPRED. The patient was not hospitalized, and was released from the emergency room. Subsequently the patient recovered. The patient had no known adverse events following prior vaccination. No product quality complaint was involved. A lot check has been requested. The events of hives on chin, then neck was considered to be immediately life-threatening and an other important medical event by the reporter. This is one of several reports received from this source. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. Follow-up information received from the nurse started "the information reported here is not consistent with any adverse experiences that happened at her office. She was not sure which patient this could be regarding." No further information was given. Follow-up information was received from the nurse who reported that on 18-MAY-2007 at 10:10 AM, the patient was seen for well child exam. A phone call from the patient's mother was received by the nurse at 16:31. The mother reported that at 16:15, she noted a rash all over the trunk and arms going up to the face. She denied that the patient had any problems breathing. The event was discussed with the physician who advised BENADRYL and to call 911 to be evaluated in the emergency room. Medical records from the emergency room indicated that the patient was seen on 18-MAY-2007 for the chief complaint of hives. The history of present illness indicated that he had a cold for two weeks, had a fever, had a sore throat, and some vomiting. He still a dry cough. He seemed to be getting better. He had a dose of VARIVAX on 18-MAY-2007. He takes CONCERTA for attention deficit/hyperactivity disorder. He had no trouble breathing. He did have some lymph nodes in the front of his throat. The hives had come up on the face, torso, and back. They were different shapes, they were itchy, and they changed locations. They were not involving his palms, soles, or mouth. He had no high fevers and was in no distress. He was an allergic type person and had no allergies to anything. Upon physical exam, he was alert and in no acute distress. His head was atraumatic and normocephalic. His skin did have hives. Most of them were across his trunk and back and up onto his neck as well. They were not involving his conjunctive, mouth, or the intraoral area. Lungs were clear with no wheezing. His heart had a regular rate and rhythm with no murmur or gallop. His belly was soft, benign, and nontender. Extremities were without clubbing, cyanosis, or edema. Neurologically he was alert and appropriate. The emergency department course indicated that he was given ORAPRED a five burst and BENADRYL. They were warned that if this involved the mucous members, to come back. They were told it could either be the viral syndrome he has right now or it could be the vaccine, though this was awfully early, and this was more of hive-type reaction rather than the other type of reaction which can occur with the vaccine. They were told to come back with any trouble breathing. He was sent out with the diagnosis of hives, after being given 25 mg of BENADRYL orally and ORAPED 2 mg per kg. It was unknown if the patient had recovered. No further information is expected.