Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 23 year old normal, healthy Caucasian male with a medical history of left shoulder surgery and no other medical history who on 3/1/02 was vaccinated with a first dose of varicella virus vaccine in the left triceps. There was no illness at the time of vaccination. It was reported that immediately after vaccination, the patient developed redness and arm discomfort, and perhaps some chills and a low grade fever. On 3/4/02 the patient presented with erythema (redness) of the injection site. Additionally, the injection site was warm and tender to the touch. The patient was treated with antibiotics for possible cellulitis. After a short course of dicloxacillin, the redness resolved (whether the diclox was responsible was uncelar). The patient's reported major complaint was continued pain in the arm, since the patient had shoulder surgery on the same side the physician reportedly was considering obtaining an MRI of that shoulder. Between then and his next visit on 3/11/02 the patient's injection site warmth/tenderness had resolved; however, the patient developed a diffuse rash and some flu-like sumptoms. He also had 3 blisters that have been lanced. In addition he had two blister-like lesions on his left anterior deltoid area, located several centimeters from the injection site. At that time, the patient was started on acyclovir for the lesions, and amitriptyline for sleep (the patient was having difficulty sleeping due to the flu-like symptoms and the pain of the blister-like lesions). On 3/18/02 the patient presented with blister like lesions which had popped according to the patient and he continued to have worsening flu-like symptoms. The patient also had tenderness in the area of the left biceps tendon, where two blisters still evident on the left shoulder. On his next follow up visit, on 3/25/02, the flu-like symptoms had resolved; however, the patient had 3 new lesions on his chest where none had been seen before. The patient was then prescribed zovirax and elavil. The physician described the lesions as red, tender and less than 0.5 centimeters in diameter. The physician did not observe that the lesions were fluid filled, though the patient reported that they had been at one time. The physician reported that the lesions were more scab-like. On 3/28/02 the physician stated that presently, the patient reports to be feeling better, though the shoulder and chest lesions are still present, and he continues to have pain at the site of the lesions and in his left shoulder. It was noted that the patient continued to develop additional lesions despite acyclovir treatment and the lesions had not improved. The physician noted that this makes it less likely that the lesions were varicella. The physician also stated that if the patient continues to have symptoms he would submit a sample for PCR analysis. The patient was scheduled to be seen on 4/1/02. On 4/1/02 the patient had more lesions, this tie on the right arm and left thigh. ON 4/8/02, the pain was reportedly better and the lesions were resolving, by 4/15/02, the pain was almost gone. On 5/20/02 the patient appeared well. However, on 8/11/02, the patient developed the same symptoms again, but, with greater severity. The patient had 100+ lesions and was vomiting. On 8/14/02 the patient was again seen with pustular like lesions on his back, tongue, and buttocks with a greater distribution on the right side as compared to the left side of his chest. The physician did not consider herpes zoster since there was not a purely dermatomal distribution. The patient also had no appetite, nausea, and vomiting and lesions in the back of his throat. He had been treated with valacyclovir HCl since 8/19/02 and although his lesions had dried and the pain was resolving the patient continued to have GI complaints which the physician contributed to the treatment with valacyclovir HCl. On 8/23/02 the physician obtained a CBC and HIV screen however the patient denied any high risk behavior. It was noted that the physician did not know of any recent exposure to natural chicken pox for the patient. On 8/23/02 the physician reported that the patient's original symptoms resolved after several weeks. However, on 8/26/02 the physician reported that the patient complained of worsening pain at the site of the rash. He stated that the patient had dried lesions last week however, today the dried lesions had fallen off and again has open vesicles. The physician reported that the patient's lab results were all normal. The physician also reported that the patient had shingles-type pain and submitted swab specimens for analysis. PCR analysis revealed the following: a large swab from the chest and 2 swabs from the leg were negative for both the wild-type varicella zoster virus and the vaccine strain virus; however the scab specimens were inadequate to process for PCR analysis. Because of pain he was given some pain medicine and on 8/30/02 the patient looked much the same but felt worse and couldn't eat. On 9/3/02 the lesions were noted to be healing but the pain was described as 10/10 with burning on urination having begun as well. The patient also saw an epidemiologist on 9/3/02. Follow up reported that the patient had severe chicken pox, which reportedly began on 3/1/02. The patient reportedly had not recovered. The reporter considered severe chicken pox as a significant disability adverse event. Additional follow up information received on 12/9/02 reported waxing/waning symptoms of nausea with transient rash, dermatology evaluation is pending. Follow up information received on 2/4/03 reported that the patient was still sick after vaccination. The reporter was awaiting an internal medicine consult. The patient had persistent symptoms of skin rash, malaise/fatigue, and GI symptoms of persistent diarrhea. It was reported that the patient was hospitalized for two days. The reporter considered skin rash, malaise/fatigue, and GI symptoms of persistent diarrhea to be other important medical events. Additional information has been requested. Reported on 02/27/2003: "Follow-up on 02/13/2003 from the reporting physician stated that the patient "is about the same."  The patient has times when he does better and then the rash reappears, and the physician just treats him for comfort measures.  The patient has been seen by an internist for one visit, and the internist cannot conclude a diagnosis for the patient.  The internist reported to the patient that he will need to do some research.  The reporter considered skin rash (transient), malaise/fatigue, and GI symptoms of persistent diarrhea to be other important medical events.  Additional information has been requested.