Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster disseminated, Injection site erythema, Injection site swelling, Polymerase chain reaction positive
Clinical narrative: Information has been received from Pfizer and was assigned manufacturer report number US-PFIZER INC-2015065838. This was originally reported by a physician concerning a 66 year old female subject enrolled in a study. The subject's concurrent conditions included 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 and nutritional supplementation. No medical history was reported. The subject had a vaccine history of childhood vaccine, tetanus vaccine, pneumonia vaccine and influenza vaccine (November 2014). 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. Concomitant therapies included New Life Formula, calcium (unspecified) + vitamin D (unspecified), Source Naturals Boswellia Extract, methotrexate (manufacturer unknown), FOSAMAX, folic acid, tramadol hydrochloride, probiotics (unspecified), temazepam, prednisone, metoprolol tartrate, NSI MEGA FMA, citalopram, aspirin, TYLENOL, omeprazole (manufacturer unknown) and ascorbic acid, general nutrients and carvedilol. 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 the dermatologist and an 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. The 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-2014, 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 was a reasonable possibility that the event of disseminated herpes zoster was related to study drug. Based on the temporal association, the event is possibly related to ZOSTAVAX. The event was not related to clinical trial procedure. Follow up information has been received from the investigator's assistant on 21-MAY-2015. On that day, a phone call was placed to the reporting physician but the call went directly to the physician's voicemail and voicemail was left to return the phone call and later, a phone call was received from the assistant who stated that this was a Pfizer sponsored study and no additional information would be shared without permission from Pfizer. No further information was available. Additional information is not expected because there is no permission to contact the sponsor. Narrative was updated. This is a new safety report and has been created due to safety report "US-009507513-1503USA010995" having been submitted with an incorrect WWID reference "US-009507513-1503USA010995" that does not refer to an existing case. "US-009507513-1503USA010995" will be nullified. The correct WWID "US-PFIZER INC-2015065838 is referenced within this safety report and will be kept as the master case file.