Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Information has been received from a licensed nurse practitioner concerning a 68 year old female with hypertension, asthma, allergy to sulfa and cephalosporins who in June 2009, was vaccinated with ZOSTAVAX (Merck) (Lot# 664122/0628Y, exp 02-NOV-2010), SC, 0.65 ml. Concomitant therapy included ADVAIR and DYAZIDE. On 02-AUG-2010 the patient experienced shingles that was diagnosed by the physician. The patient had sought medical attention. At the time of the report, the patient had not recovered from the event. On 05-AUG-2010, a call was given to the physician office to speak with the licensed nurse practitioner regarding their interest in the VZVIP. The licensed nurse practitioner confirmed that they received the VZVIP fax. She explained that she was trying to contact the patient to offer the program. She explained that the patient was seen in the office on 02-AUG-2010 and her shingles were on the right side of her abdomen and went around to her back in the T9-T12 dermatomes. She described the patient's shingles as big fluid filled lesions. The physician treated the patient with FAMVIR 500 mg TID for 10 days. On 05-AUG-2010 a call was received from the licensed nurse practitioner who reported that the patient was seen in the office today and 3 samples were collected to submit to the VZVIP program. She confirmed that the samples would be shipped on 10-AUG-2010. On 06-AUG-2010 a call was received from the licensed nurse practitioner regarding the samples. She stated that the samples would be shipped on Tuesday 10-AUG-2010 because their office was closed on Monday. She said the patient was "not much better" when she was seen in the office. The patient still had lesions with a lot of fluid and they were able to collect 3 good swabs full of fluid. The licensed nurse practitioner stated that the patient was in a lot of pain with a rating of 8 on a pain scale of 1-10. The physician prescribed LORTAB prn for pain. The licensed nurse practitioner confirmed that the patient was diagnosed with shingles. She said it was a classic case of shingles and "one of the worst cases of shingles they had had". Follow up information was received from the physician who reported that the patient with no recent exposure to chickenpox or herpes zoster and a history of hives while on angiotensin converting enzyme (ACE), arthralgia while on statins and chickenpox rash in 1952 when she was 10 years old who was vaccinated with ZOSTAVAX (Merck) (Lot# 664122/0628Y,), SC, 0.5 ml (previously reported as "0.65 ml") in her left arm. On 31-JUL-2010, she developed varicella zoster/herpes zoster, a painful rash, conjuctival of multiple lesions, lesions distribution was right T9-10-11 dermatome. The maximum temperature was 100 degree. At the time of the report, the patient had recovered from the event. There is no rash occur at the site of injection or elsewhere within 42 days of the vaccination. 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 Merck vaccine strain. Lesion samples were collected on 05-AUG-2010. The samples were taken from vesicular lesions on the patient's right lateral, right front and right posterior. The sample were sent to the laboratory on the same day. VZV DNA was amplified and B-globin DNA was amplified. The PCR result from the scab specimen identified the presence of WT VZV. No further information is available.