Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Culture urine positive, Cystitis, Gait disturbance, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 61 year old female who has osteopenia, increased cholesterol and allergies to penicillin, Zithromax, dilantin, "estromen" and vitamins and a history of herpes zoster exposure, who was vaccinated in the right arm with a dose of Zostavax (lot#656394/0162U). Concomitant therapy included alendronate sodium, ezetimibe, and celecoxib (CELECOXIB). It was reported that a patient who developed "zoster" two days after receiving Zostavax has experienced postherpetic neuralgia (PHN) for five weeks. It was reported that the patient has not yet recovered. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from the physician and consumer indicating that the patient has no history of chickenpox or shingles in the past. The patient was exposed to shingles in the past, but never developed shingles. The patient was vaccinated in the right arm with Zostavax on 20-Mar-2007. Immediately following the vaccination the patient experienced flu like symptoms. The patient also had complaints of lower back pain. The patient went to her chiropractor for the lower back pain and a "complete profile of her immune system was run which was reported as normal". She also had a urine specimen sent which showed a severe bladder infection. She was treated with a "sulfa drug". Two days later on 22-Mar-2007 (also reported as 21-Mar-2007), she developed a rash on her right leg to great toe and her buttock. They were small circular lesions. She also developed a lot of pain which she rated as a 10. The lesions turned into a straight line formation and they were filled with fluid. The initial physician stated that it was just a rash and to use cortisone. She returned to the original physician after the weekend and the rash was not better. She stated that the physician never said it was shingles and treated her with prednisone. The patient decided to go to a new physician. The new physician gave her a penicillin derivation "to kill the bacteria in her urine". The patient reported that she was treated with pregabalin (LYRICA), 75 mg three times daily for the rash which seems to be helping her. She also used a "Lidocaine patch" when the pain was really bad. To date the patient still has pain and her lesions have turned to scabs. on 07-May-2007, a specimen was sent for PCR analysis. 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 was a vesicle lesion and scabs. The patient has not yet recovered. Follow-up information was received from a registered nurse from the physician's office indicating that her office was not the office that vaccinated the patient. They saw the patient after she experienced the rash. The nurse stated that the patient was never diagnosed with shingles. Additional information has been requested. This is in follow-up is report(s) previously sumitted on 6/14/2007. Follow-up information received from physician that the PCR results from the specimen was identified as postive for the presence of wild type VZV. Follow-up infomation received from the physician indicating that the patient was a 61 year old female weighing 154lb and was 63 inches tall. Patient received zoster vaccine live (Oka/Merck) on the inside of the right arm. The following occurred after the patient received the vaccination, 20-MAR-2007, patient developed flu-like symptoms, 21-MAR-2007 senations in right leg, 27-MAR-2007, rash began, 23-MAR-2007, patient saw chiropractor. He noticed  the rash and told patient to return to her physician. The physician told the patent it was a rash, not shingles and to applyCort-Aid. 24-MAR-2007, patient could not flex leg or walk. 26-MAR-2007, patient saw another physician who took pictures of the leg.Patient was told that he couldn't give the ant-viral because it was outsie the two days. Prescription for prednisone and lidocaine patch were givemn. Rash began at buttocks and traveled down inner thigh of right leg. Rash was in its third month. Multiple lesions moset profound on front of right leg. Patient ranked pain at 10. Patient was cintinuing recovery process. No additonal information is expected.