Age: 1.12
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Injection site vesicles, Local reaction, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (route and lot number not reported). On an unknown date, the patient experienced "severe local reaction", this included blisters, rash, redness, fever and swelled to twice the size of his arm. The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from a nurse concerning a male patient who on 12-DEC-2002, was vaccinated with the first dose of VARIVAX (Merck) (lot number 635790/0199M). On 22-APR-2011, was vaccinated with the second dose of VARIVAX (Merck) (lot number 668617/1060Z). The patient did not receive any concomitant vaccinations. On an unknown date, the patient developed blisters on his left arm. The left arm became swollen and red. The patient was treated with prednisone and cold compresses. The nurse stated that the patient had recovered. Follow-up information was received from a licensed practical nurse who provided medical records concerning a 9 year old male with a penicillin allergy and a history of tonsillectomy. On 22-APR-2011, the patient was seen by his physician for possible attention-deficit hyperactivity disorder. His height was 60.5 inches, weight was 231 pound and body mass index was 44.3. The patient's vital signs were: blood pressure 134/62 and temperature (oral): 97. The physician's assessment was attention-deficit hyperactivity disorder and the patient was prescribed INTUNIV 1-2 mg. At this visit, at 15:30 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 668617/1060Z), subcutaneously in his left arm. On 23-APR-2011 at 08:00, the patient developed induration, erythema and swelling of the entire extremity with blister formation. On 24-APR-2011 at 19:28, the patient was seen in the emergency department with a chief complaint of redness/blister of the left upper arm. A skin rash that was itchy, tender and painful was noted on the patient's left upper arm. The patient reported a pain scale of five. A possible identified cause was that the patient, just prior to the symptoms, had exposure to the chicken pox immunization. An adverse drug reaction: "[chicken pox vaccine]" was noted. The patient's vital signs were: temperature 98.4, blood pressure 147/61 and pulse 110. The patient was treated with sulfamethoxazole and BACTRIM DS and discharged. On 25-APR-2011, the patient was seen by his physician. The patient's vital signs were: temperature 97.1 and blood pressure 120/72. The physical exam showed blisters at injection site-probable VARIVAX (Merck) reaction. The assessment: reaction to vaccine. The plan included prednisone, ATARAX and ice compresses. On 27-APR-2011, the patient had a follow-up visit to check the arm. The current medications were guanfacine, hydroxyzine, clindamycin and prednisone. The patient's vital signs were:  temperature 98.5 and blood pressure 128/70. The assessment: reaction to VARIVAX (Merck). The Induration, erythema and swelling of entire extremity with blisters resolved by 29-APR-2011. This is one of several reports received from the same source. All available medical records will be provided upon request. Additional information has been requested.