Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin plaque
Clinical narrative: Information has been received from a consumer concerning her husband, an 81 year old male with no pertinent medical history and no drug reactions/allergies who in approximately October 2009, was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (LOT# not reported). Concomitant therapy included benazepril HCl, metformin HCl, aspirin, vitamins (unspecified) and ezetimibe (+) simvastatin. Ezetimibe (+) simvastatin was been take off on an unspecified date. The wife reported that in approximately November 2009, the patient experienced a "body itch" as a result from having the ZOSTAVAX (Merck). The wife stated that her husband had "gotten the shot almost a year ago and that his condition was worsening. There was no rash; however, her husband was bleeding from scratching his skin". He had seen an allergist, neurologist, and dermatologist; he's had blood work done and a biopsy. The patient's condition didn't resolve, he was getting worse. PPI was requested. Follow up information received from a physician via medical records indicated that the patient was a retired male, with Pruritis, Hypertension, Osteoarthritis, Type 2 diabetes mellitus, Macular degeneration, Hyperlipidaemia and a history of TA Venous ligation, who on 12-NOV-2009 (previously reported as approximately in October 2009) was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) (Lot# 664635/0836Y). Concomitant therapy also included hydroxyzine. On 27-APR-2010 the patient was seen at the physician's office; it was reported that in October 2009, the patient began to note pruritus. Since that time the patient has continued to have itching primarily about the trunk which waxes and wanes during the day and will at times bother him at night and awake him from sleep. Itching was primarily along the posterolateral, lateral and anterolateral thorax regions, but also along the anterior chest and shoulders and occasionally he developed pruritus between the thighs and about the knees. At times he noticed that pruritus tends to occurred at pressure points. The symptoms were migratory tending to be one place for a period of time and then moved to another. He was treated with local creams without success. More recently he had been tried ATARAX at night which was helpful for sleep. As the patient continued to have these complaints, he was referred for neurologic evaluation. The neurologic evaluation was within normal limits. At the time of the patient's visit to the physician's office his physical examination was within normal limits. The patient's assessment was idiopathic, migratory pruritus (referred as neurodermatitis). The patient was prescribed gabapentin 100 mg TID; if no improvement was observed in two weeks the dose will be double to 200 mg TID. On 07-JUN-2010 the patient presented to physician's office complaining of many red bumps on body: the patient's treatment included permethrin and a neurology consult. At this the patient's physical examination was within normal limits. On 09-JUN-2010 the patient had a skin, back, punch biopsy which showed mild epidermal hyperplasia and spongiosis. Dermis is edematous and contains mononuclear cell infiltrates around dilated telangiectatic vessels with marginating neutrophils. A rare eosinophil is present. Extravasated red blood cells in one focal area suggest trauma rather than a purpuric process. On 18-JUN-2010 the dermatologist informed the patient that the biopsy results were not very specific but seemed most consistent with a mild allergy or possible insect bite. There was no definitive cause. A new lesion may need to be biopsied. The patient was recommended to use topical steroids and antihistamines. On 21-JUN-2010 the patient presented to the physician's office with red bumps and small scaling plaques; the biopsy was not every revealing of etiology, this showed mild allergic reaction vs bites. Physical examination was within normal limits. The patient was treated with triamcinolone acetonide 0.025% EX LOTN - application to affected areas BID. On 12-AUG-2010 the patient presented to the physician office and reported minimal relief from pruritus, which was distributed primarily over the extremities and torso. Topical high potency steroid and oral antihistamine were tried for several day to minimal avail. The patient denied flushing, excessive diaphoresis/night sweats, fatigue, anorexia, fever, chills, CI, GU or respiratory symptoms, dietary, medication or dosage changes. The preponderance of the pruritus occurred in areas of skin free of visible lesions or xerosis, and in fact the small erythematous papules and small scaling plaques noted in dermatology appeared very minimally. Scratching did not elicit a dermatographic response. Physical examination was within normal limits. On 30-JUL-2010 the patient had the following laboratories test performed: red blood cell count (4.24), blood hemoglobin test (13.2), whole blood hematocrit (38.9), urine protein test (1+, abnormal), serum sodium test (134), serum chloride test (94), serum glucose test (165), glomerular filtration rate (56) and serum magnesium test (1.5). At the time of this report the patient had not recovered. Additional information has been requested.