Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion, Varicella zoster serology negative
Clinical narrative: Initial and follow-up information has been received from a pharmacist and a 76 year old male with no pertinent medical history and a penicillin allergy who on 24-OCT-2007 was vaccinated with one single dose of Zostavax (Oka/Merck). Concomitant drug therapy included digoxin, ramipril (ALTACE), warfarin sodium (COUMADIN) and olmesartan medoxomil (BENICAR). On approximately 31-OCT-2007 the patient developed rashes on his stomach, back, legs and ankles which caused itching, but no fever. The patient sought unspecified medical attention where two different physicians "thought it was shingles." No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. The patient was enrolled in the VZIP enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present, to identify if it is associated with the wild-type VZV strain or the Oka vaccine VZV strain. Additional follow-up information has been received from a physician indicating that a 76 year old patient with a history of chickenpox and a penicillin allergy who on 24-OCT-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot# 658084/0888U) in the left arm. Other concomitant drug therapy included: aspirin, saw palmetto, fexofenadine HCl (Allegra), olmesartan medoxomil drug therapy included: aspirin, saw palmetto, fexofenadine HCl (Allegra), olmesartan medoxomil (Benicar), digoxin (Digitek), ramipril (Altace) and warfarin sodium (Coumadin). On that same day the patient was seen in the office for superficial cellulitis on his forearm that he had for 1 week. The physician noticed a rash of 3 multiple vesicular disseminated lesions under his right axilla that were a week old with a moderate pain level of 4. The patient developed recent exposure to herpes zoster on approximately 17-OCT-2007. The physician noted to patient that since he had shingles, he had been vaccinated too late. No direct fluorescent antibody (DFA), PCR or photo was done. The patient declined theory and on 31-OCT-2007 the patient was seen by another physician who prescribed valacyclovir HCl (Valtrex) for shingles. Subsequently the patient recovered. Additional follow-up information has been received from a 76 year old male who was referred to a dermatologist by the reporting primary care physician that stated his rashes, "may be dermatitis or eczema" and prescribed Clobetasol Propionate. "This medicine seems to be helping and clearing it up." Additional information has been requested. 03/26/2008 Additional follow-up information indicated that a dermatology evaluation was performed due to a "reaction" to vaccination with ZOSTAVAX (Oka/Merck) (lot# 658084/0888U). The reporter stated that the vaccination was not administered by the physician's office. The reporter also stated that there was no correlation between the vaccination and the patient's reaction/rash. Additional information has been requested. 02/12/2010 Additional follow-up information indiciated the rash ahd not cleard up yeat and it's all over his body. The patient had seen 3 dermatologists and an allergist. Additional follow-up information from the patient indicated that the trash had not cleared up and was still burning and itching. The patient added that he was also taking VALTREX and asked if new information was available regarding his condition. Additional follow-up information from the patient indicated that he received the shingles vaccination on 24_OCT-2007. Within a few days he developed a fluid-filled type of lesion on his upper body, and within a week, a type of eczema on his lower torso and legs. The patient saw two dermatilogiests who would not say the upper lesions were shingles or not. Getting very l ittle relief from VALTREX and topical cortisone creams, he then saw an allergist, who did not think it was an allergic reaction. The patient was treated the patient with a four day regimen (Predinsone) that did not help. Additional follow-up information fromt eh patient's wife indicated that her husband was experiencing a bad rash on his body with some itching. The patient's wife and the patient both received ZOSTAVAX on 24-OCT-2007. Three days later on approximately 27-OCT-2007 he broke out in lesions and they have not gone away (she did not experience any reaction to tthe vaccine). They ahve been to a dermatologist and an allergist and both physicians could not identify the cause of the lesions. The patient's rash was continuing at the time of this report. Addditional follow-up from a primary care physician, dermatologist and medical records indicated that on 14-MAY-2008 the primary car physician's office was contacted to obtain additional information regarding the case and discuss VZVIF. The receptionist indeicted that the physician was seeing patients. The primary care physician indicated that the patient received the "shingles shot on the same day he ahd shingles." She explained that she wrote the patient an prescription for his ZOSTAVAX. Sh e explained that he was vaccinated with ZOSTAVAX (lot# 658084/0888U) in the left deltoid and he did ot informthe clinic that he ahd an active outbreak on his right arm and torso at the time of vaccination. It was explained to the pysician that both the patient and his wife reported on several occasions to mention that the rash ahd not cleared up. The patient currently had dark blotches on his abdomen and a slightly raised nodule in the axilla area of his upper arm. She mentione that a previous biopsy showed superficial dermatitis. She told the patient she would be willing to remove the larger raised nodule in the office. PCR testing for the VZVIP program on this possible sample was discussed. The dermatologist was also contacted for the case and the dermatologsit was familiar with the patient and indicated that he saw the patient at the end of February. A the time he basically had an eczema-like rash. A punch biopsy was performed in January which showed spongiotic dermatitis. The physician did not feel it was realted to the vaccine. He indicated that the patient never presented to his office with fluid-filled vesicles, but more of an eczema reaction. On 03-MAR-2008 a tissue pathology report revealed the patient had erythematous papules and nodules randomly scattered to right upper arm and right abdomen increaslingly in groups and clusters and was not responive to class I topical steroid ointments. The right forearm and right abdomen showed superficial and deep perivascular and interstiaial dermatitis with eosinophils. The patient had a history of eczema, arthroipod assault versus viral eruptions. Overall, the findings probably represent an arthropod bite reaction particularly includeing scabies. However, no scabies mites were identified in the sections examined. There were a few enlarged cells in the inflitrate, but they were negative for CD30. PAS stain for fungi was negative. Multiple sections have been examined. The multiple attempts were made to reach patient's primary care physician as well as the consulting dermatologist for the VZVIP program previously. The patient's wife mentioned that she ould be seeing the primary care physician that same day. The consumer was continuing to pursue follow-up to request information. The patient was enrolled in the VZVIP: the program enables biological sampleseot be analyzed by PCR to idenify if VZV is present and if it is present, to identify if it is associated with the wild-type VZV strain or the Oka vaccine VZV strain. Additional follow up was reported for the final PCR results on swab specimen for this case.. The swab contained fluid from a "nodule" and PCR analysis revealed it was negative for VZV. PCR results were pending for the tissue sample from the nodule. The reportign primary care physician was seeing patients and was unavailable, however; a nurse in the reporting primary care physician's office was notified about the swab specimen that was VZV negative and the pending results for the nodule. Confirmation of the final PCR results for both specimens will be sent to the office in writing. Additional information has been requested. All available medical records will be provided upon request. This is in follow-up to report (s) previously submittedon 12/21/2007, 3/26/2008, 6/24/2008, 9/24/2008.