Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive, Viral infection, Viral test positive, White blood cell count decreased
Clinical narrative: Disseminated varicella zoster vaccine virus infection; Contraindicated product administered; Literature Report:  This literature marketed report was received from the authors in a published literature article title as stated above, concerning a 33-year-old man presented with a generalized, painful, pruritic rash and mouth lesions. He received a varicella vaccine (VAR) varicella virus vaccine live (oka/merck)(manufacturer unknown) 3 weeks prior, at a pharmacy clinic, to fulfill employment requirements (Contraindicated product administered). He had difficulty with the computerized kiosk when registering, so the nurse practitioner bypassed the usual procedure of eliciting contraindications and vaccinated him. He grew up and did not have a history of chickenpox or of receiving VAR. His medical history included end-stage renal disease secondary to hypertension and receiving a deceased donor kidney 7 months prior. Pretransplant evaluation nearly a year before transplant included negative VZV and positive cytomegalovirus serology, and pretransplant VAR vaccination was missed. Antithymocyte globulin induction therapy was administered during his transplant, with immediate graft function posttransplant. He was maintained on 3 months of valganciclovir and 6 months of trimethoprim-sulfamethoxazole for cytomegalovirus and Pneumocystis jiroveci pneumonia prophylaxis, respectively.  His posttransplant course had been unremarkable; he had not required immunosuppression augmentation for rejection, experienced delayed graft function, or had an adjustment of his immunosuppressants before receiving VAR. Medications included mycophenolate 720 mg twice a day, prednisone 5 mg daily, and tacrolimus 20 mg daily, with target level 6 to 8 ng/mL. He lived alone and did not use tobacco, alcohol, or illicit drugs. He did not have any known contact with anyone who recently received VAR. Laboratory tests 5 weeks before receipt of VAR included a tacrolimus level of 10 ng/mL, leukocyte concentration of 4150 cells/µL (absolute lymphocyte count, 840 cells/µL), stable allograft function with creatinine level of 1.73 mg/dL, and normal liver enzymes (aspartate aminotransferase, 19 U/L; alanine transaminase, 12 U/L). On examination, his temperature was 39.9 °C, blood pressure 138/87 mmHg, pulse 126 beats/minute, respiration 19 breaths/minute, and oxygen saturation 98% on ambient air.   He appeared ill. Skin examination revealed generalized and agminate vesicles on an erythematous base on the scalp, face, trunk, and extremities, with some facial vesicles demonstrating central erosion and umbilication. Significant laboratory data revealed a leukocyte count of 2400 cells/µL (normal, 4200-10,700) with absolute lymphocyte count 410 cells/µL (normal, 1090-3230), creatinine 1.81 mg/dL, aspartate aminotransferase 247 units/L (normal, 13-40), alanine transaminase 246 units/L (normal, 5-50), and tacrolimus level 10 ng/mL. Tests for syphilis, hepatitis B/C, human immunodeficiency virus, severe acute respiratory syndrome coronavirus 2, and Cryptococcus antigen were negative. Blood and urine cultures were negative. Chest radiograph was normal, and computed tomography scan showed normal liver and transplanted kidney.  Skin smear preparation with Wright stain demonstrated keratinocytes with viral changes. The viral polymerase chain reaction swabs from his arm and mouth were positive for VZV and negative for herpes simplex virus type 1/2. Acid-fast bacillus, bacterial, and fungal skin cultures were negative. A skin biopsy sent to the Centers for Disease Control and Prevention (CDC) for genotyping confirmed vaccine-strain VZV (vOka) (Disseminated varicella zoster vaccine virus infection).  He was treated for disseminated varicella, complicated by suspected varicella hepatitis, with acyclovir 600 mg intravenously every 8 hours. His immunosuppressant regimen was decreased to mycophenolate 360 mg twice a day, tacrolimus 8 mg (levels decreased to target level 6 ng/mL), and continued prednisone 5 mg daily. After 6 days, he transitioned to oral valacyclovir and completed a 14-day treatment course, with improvement in his rash, pain, and transaminases. The administering clinic was contacted, which noted the preventable error and relayed that procedures were in place to prevent future inadvertent varicella vaccinations. A year after discharge, he felt well but had widespread skin discoloration resulting from the rash.  Upon internal review the event Disseminated varicella zoster vaccine virus infection was considered serious as medically significant.   A copy of the published article is attached as further documentation of the patient's experience.