Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Angioedema, Blood thyroid stimulating hormone normal, Full blood count normal, Idiopathic urticaria, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old caucasian male patient with no allergies or medical history who on 04-MAY-2007 at 15:30 pm was vaccinated IM in the left deltoid with the first 0.5 ml dose of hepatitis A virus vaccine inactivated (lot number 656993/0001U). Suspect vaccine administered the same day included a SC, left deltoid injection of the second 0.5 mL of Varivax (lot number 656574/0117U). There was no concomitant medication. There was no illness at the time of vaccination. There was no known adverse events following prior vaccinations. On 08-MAY-2007 the patient developed hives on his trunk and on the back of his thighs. On 09-MAY-2007 the patients hives spread to his feet, hand and lips. The physician prescribed 50mg/ml BENADRYL and a dose pack of MEDROL. The patients status was recovering. No diagnostic laboratory tests were performed. No product quality complaint was involved. Information was received from the administering pediatrician reporting that on 08-MAY-2007, the mother reported hives on the patient's hands, feet, lips and most of his body. Treatment with 50mg/ml BENADRYL and a dose pack of MEDROL was prescribed. The hives continued and the patient was referred to the allergist. The patient's status at the time of the report was unknown. Additional information from the allergist included medical records and laboratory results. On 30-May-2007 the allergist reported that the patient was evaluated. It was reported that the patient developed acute urticaria on 08-MAY-2007. This was four days prior to him receiving the vaccinations with hepatitis A virus vaccine inactivated and Varivax. He initially started with raised pruritic lesions which traveled around his body and then progressed in severity and intensity to large more plaque-like lesions angioedema of the lips and feet. At time his feet were painful. He was started on a dose pack of MEDROL without improvement. He was taking 25-50mg every six hours which provided some relief of itching. Slowly over a period of 7-14 days the severity of his skin eruption ceased and as of now he is getting lesions every several days. It was also reported that the patient had a fever of 100.7F 2-3 days after hives developed. No specific triggers have been identified to include foods or topical irritants. No changes in urticaria with him taking non-steroidial anti-inflammatory drugs (NSAIDS). He is otherwise healthy and does not take any medications routinely. On physical exam his height 66-1/2 inches and his weight was 137 pounds. His blood pressure was 116/78. The physical exam was unremarkable. Screening laboratory tests were obtained on 26-MAY-2007 at 10:54 am that included a venipuncture for samples and a routine urinalysis. Tests ordered included a complete blood count with differential and platelet count; a complete metabolic panel; urinalysis routine; thyroid panel with a thyroid stimulating hormone level and a sedimentation rate-westgren. The testing results were documented and to be within normal limits with the exception of the complete blood count. It was noted that the Neutrophil count = 66% and lymphocyte = 25%. The allergist diagnosed the patient with chronic idiopathic urticaria and angioedema. His treatment plan included ZYRTEC 10 mg daily and ZANTAC 150 mg two times a day with breakthrough hives he may take BENADRYL 25-50 mg every six hours as needed. The allergist also reported that it was unlikely that his vaccinations were a specific trigger to his eruption of urticaria though remotely possible. The risk of infections which would be prevented from his vaccinations would outweigh any risks from further outbreaks of urticaria with subsequent vaccinations. The allergist recommends further vaccinations as scheduled including hepatitis A vaccine inactivated boosted in six months. It was recommended that the patient have a follow-up appointment in three months and as needed. At the time of the report the patient's status was recovering. The patient's adverse event was considered to be other important medical event. The patient's experience was considered to be serious by the reporter. Additional information not expected. Medical records are available upon request.