Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound Doppler normal, Viral test
Clinical narrative: Information has been received from a physician concerning a 62 year old female with a medical history of chickenpox and no drug allergies who on 09-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX in her right upper arm (lot # 659406/0298X). There was no concomitant medication. On 14-JUL-2008, the patient developed cramps on her right side and a red, papular rash that ran from the right side of her waist down along L-1 and L-2 dermatomes. The rash went as far as the top of her right knee. There were no vesicles present, but there were groups of papules. There was no fever. The patient was sensitive to touch, burning itchy pain with no systemic symptoms. The patient was diagnosed with shingles and treated with VALTREX. The patient had no fever. The pain was starting across lower abdomen, moving to right upper leg and around to right hip. The area was swabbed and also crapped with slide to obtain an adequate sample. There was approximately 50 lesions 1 cm made up of confluent papules in each patch, starting above right knee and running up leg around up right buttock to waist. The patient was recovering. No product quality complaint was involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 23-JUL-2008. The sample was taken from a papular lesion. The results was inadequate specimen, negative for B-globin and no strain I.D. Follow up information was received concerning that a lot check was requested.  Follow up information was received which reported that on 09-JUL-2008, the white patient received vaccine. There was no illness at the time of vaccination. On 14-JUL-2008, the patient began to get pain in lower abdomen. On 15-JUL-2008, pain increased and moved to lower right abdomen and top of right leg. On 17-JUL-2008, the patient's family doctor sent her to the hospital for an ultrasound of her right leg ruling out a blood clot. On 19-JUL-2008, rash started 5 inches above right knee. 21-JUL-2008, rash running 5 inches above right knee, up leg around and up right buttock to waist. On 22-JUL-2008, the patient was diagnosed shingles and given VALTREX and prednisone. Real time sonography of the right lower extremity deep venous system obtained from the level of the common femoral vein to the calf. Unremarkable compressibility and flow noted throughout. No evidence of echogenic intraluminal filling defect. Impression: no sonographic evidence of right lower extremity deep venous thrombosis. This is one of several reports received from the same source. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. A standard lot check investigation was performed. All in- process quality checks for the lot number in question were satisfactory. The lot met the requirement of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.