Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster disseminated, Injection site erythema, Injection site swelling, Polymerase chain reaction
Clinical narrative: Information has been received from an investigator concerning a 66 year old female subject enrolled in a study. The subject's current condition includes rheumatoid arthritis, osteopenia, sleep disorder, palpitations, depression, gastrooesophageal reflux disease, fatigue, eye pruritus, nocturia, myopia, seasonal allergy, increased tendency to bruise, alopecia, pain in extremity, skin discolouration, anxiety, postmenopause, rhinorrhoea, sleep disorder, nutritional supplementation. No medical history was reported. Subject had a vaccine history of childhood vaccine, tetanus vaccine, pneumonia vaccine and influenza vaccine (unk-NOV-2014). Concomitant therapies included New Life Formula, calcium (unspecified) + vitamin D (unspecified), Source Naturals Boswellia Extract, methotrexate, FOSAMAX, folic acid, tramadol hydrochloride, probiotics (unspecified), temazepam, prednisone, metoprolol tartrate, NSI MEGA EFA, citalopram, aspirin, TYLENOL, omeprazole and ascorbic acid, herbal NOS, general nutrients and carvedilol. On 13-JAN-2015 at 10:25 hrs, the subject was vaccinated with ZOSTAVAX (Lot# K010732, expiry date: 31-OCT-2015), subcutaneously in the right arm. Other suspect therapy included tofacitinib citrate/placebo, started on 27-JAN-2015 twice a day orally for rheumatoid arthritis. On 29-JAN-2015, the subject experienced herpes zoster disseminated. The subject reported that a few days after starting the tofacitinib citrate, she began to experience irritated lesions on various areas of her body which were non-painful however itchy. She also reported that the area where she received her shingles vaccine became slightly swollen and reddened about 2 weeks after receiving the vaccine. The subject was referred to dermatologist and appropriate testing was performed. On 12-FEB-2015, punch biopsy right arm was performed which revealed mixed deep granulomatous perivascular inflammation with fibrinoid degeneration of vessel walls. On the same day punch biopsy of left abdomen was morphologically compatible with VZV infection. On 12-FEB-2015, after the testing, the subject was diagnosed with herpes zoster disseminated. Subject was treated with VALTREX. The subject was withdrawn permanently from tofacitinib citrate and she took her last dose of tofacitinib citrate on 10-FEB-2015. On 24-FEB-2015, the outcome of herpes zoster disseminated was reported as recovered/resolved. The investigator considered there was a reasonable possibility that the event disseminated herpes zoster was related to the tofacitinib citrate and ZOSTAVAX and there was not a reasonable possibility that the event disseminated herpes zoster was related to clinical trial procedure. The investigator considered the event to be medically significant. Case assessment: Based on the known immunosuppressive properties, there is a reasonable possibility that the event of disseminated herpes zoster is related to study drug. Based on the temporal association, the event is possibly related to concomitant drug ZOSTAVAX. The event is not related to clinical trial procedure. Additional information has been requested. Information has been received from an investigator concerning a 66 year old female subject enrolled in a study. The subject's current condition includes rheumatoid arthritis, osteopenia, sleep disorder, palpitations, depression, gastrooesophageal reflux disease, fatigue, eye pruritus, nocturia, myopia, seasonal allergy, increased tendency to bruise, alopecia, pain in extremity, skin discolouration, anxiety, postmenopause, rhinorrhoea, sleep disorder, nutritional supplementation. No medical history was reported. Subject had a vaccine history of childhood vaccine, tetanus vaccine, pneumonia vaccine and influenza vaccine (unk-NOV-2014). Concomitant therapies included New Life Formula, calcium (unspecified) + vitamin D (unspecified), Source Naturals Boswellia Extract, methotrexate, FOSAMAX, folic acid, tramadol hydrochloride, probiotics (unspecified), temazepam, prednisone, metoprolol tartrate, NSI MEGA EFA, citalopram, aspirin, TYLENOL, omeprazole and ascorbic acid, herbal NOS, general nutrients and carvedilol. On 13-JAN-2015 at 10:25 hrs, the subject was vaccinated with ZOSTAVAX (Lot# K010732, expiry date: 31-OCT-2015), subcutaneously in the right arm. Other suspect therapy included tofacitinib citrate/placebo, started on 27-JAN-2015 twice a day orally for rheumatoid arthritis. On 29-JAN-2015, the subject experienced herpes zoster disseminated. The subject reported that a few days after starting the tofacitinib citrate, she began to experience irritated lesions on various areas of her body which were non-painful however itchy. She also reported that the area where she received her shingles vaccine became slightly swollen and reddened about 2 weeks after receiving the vaccine. The subject was referred to dermatologist and appropriate testing was performed. On 12-FEB-2015, punch biopsy right arm was performed which revealed mixed deep granulomatous perivascular inflammation with fibrinoid degeneration of vessel walls. On the same day punch biopsy of left abdomen was morphologically compatible with VZV infection. On 12-FEB-2015, after the testing, the subject was diagnosed with herpes zoster disseminated. Subject was treated with VALTREX. The subject was withdrawn permanently from tofacitinib citrate and she took her last dose of tofacitinib citrate on 10-FEB-2015. On 24-FEB-2015, the outcome of herpes zoster disseminated was reported as recovered/resolved. The investigator considered there was a reasonable possibility that the event disseminated herpes zoster was related to the tofacitinib citrate and ZOSTAVAX and there was not a reasonable possibility that the event disseminated herpes zoster was related to clinical trial procedure. The investigator considered the event to be medically significant. Case assessment: Based on the known immunosuppressive properties, there is a reasonable possibility that the event of disseminated herpes zoster is related to study drug. Based on the temporal association, the event is possibly related to concomitant drug ZOSTAVAX. The event is not related to clinical trial procedure. Additional information has been requested.