Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from two different pharmacists on 03-NOV-2015 and on 04-NOV-2015, referring to a 76 year old female patient. The patient's concurrent conditions included dermographia. The patient had drug reactions or was allergic to codeine, azithromycin, cephalexin, opiates, penicillin (captured in MARRS # 1511USA014721) and sulfa drugs. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, 0.65 ml, subcutaneously in her left triceps area, lot # K020186, expiration date 27-JAN-2016. Concomitant therapies included sertraline hydrochloride and an unspecified thyroid medication. It was reported that on 28-OCT-2015 (also reported as "the day after"), the patient noticed her injection site was red and warm, with a red area that "came and went". It was also reported that "one day the redness and raised area was a little more pronounced than other days". Later, on 29-OCT-2015, the patient looked at her injection site under a magnifying glass and noticed that she was developing a rash. This rash was localized to the injection site, was red with rough edges, and it was the size of a half-dollar. On the same date, the patient also started feeling feverish. Then, between that day and the beginning of November 2015, the rash also became itchy and tender. Subsequently, on 04-NOV-2015 at the morning, the rash was still localized to the injection site but had doubled in size. The patient said that she was going to start BENADRYL as treatment. However, at the moment of this report, the patient had not yet received specific treatment for any of the events. At the time of the report, the outcome of rash pruritic, injection site warmth, injection site erythema, rash and rash erythematous was reported as not recovered/not resolved. The outcome of pyrexia was reported as recovering/resolving (also reported as "her fever has subsided"). The relatedness between the events and the ZOSTAVAX was not provided. This case did not involve cancer, the patient did not die, there was no hospitalization and no product quality complaint was involved. Follow-up information was received from the pharmacist on 25-NOV-2015. The patient's physician confirmed that "the patient had a full-blown case internal shingles", however, the internal shingles had not gone into a dermatological lesion beyond the red injection site. The injections site did have some demarcation/erythema, but the injection site was not raised. It was also reported that the "injection site was the only area that had any discoloration" and there were no other visible signs of shingles. On an unspecified date, the patient complained of arthritic symptoms in both of her legs. The reporting pharmacist believed that the patient did not appear to have an active case of shingles. The patient returned/called to the pharmacy at least 1 time a week since the initial report. The patient had also visited her physician at least 4 times within the last 29 days post vaccination and the doctor has put her on 2 different antiviral medications (details not specified). The patient was also prescribed initially with valacyclovir (manufacturer unknown) (1g, every 8 hours for 8 days) from 04-NOV-2015 to 17-NOV-2015, and later with acyclovir (manufacturer unknown) (2 tablets, 5 times a day) for one week. The outcome of the events "herpes zoster", "vaccination site discoloration" and "arthropathy" was unknown. The relatedness of these events with the suspect product ZOSTAVAX was unknown. Follow up information has been received from the pharmacist on 25-JAN-2016 regarding the 76 year old female patient. The patient was not sure if she had a history of chickenpox or herpes zoster. She had a diagnosis of dermographia following an allergy skin scratch test. The patient was vaccinated with the first dose of ZOSTAVAX, there was no illness at the time of vaccination. The patient's concomitant therapies included sertraline hydrochloride 50 mg, daily. On 29-OCT-2015 (previously reported 28-OCT-2015), the patient presented with red warm half dollar size red spot at the injection site. She also complained of joint pain primarily in ankles and knees, swollen glands and leg weakness. It was reported that there was a rash at the site of injection or elsewhere 2 days after vaccination and there was no recent exposure to chickenpox. There was 1 lesion with duration of approximately 30 days or 4 weeks. The pain reported was 5 on a 0-10 scale where 0 is no pain and 10 is maximum pain. No specimen was collected for polymerase chain reaction (PCR) because the patient refused. Additionally the pharmacist was not sure if there were other diagnostic tests performed. On an unspecified date in November 2015, the patient was treated with prescribed acyclovir 400 IU tablets, for 5 days and on 04-NOV-2015, the patient was treated with valacyclovir 1 gram, every 8 hours for 10 days. The reporter pharmacist considered the events of herpes zoster, joint pain primarily in ankles and knees, swollen glands and leg weakness serious due to disability. The outcome of herpes zoster, joint primarily in ankles and knees, swollen glands and leg weakness was reported as not recovered. Additional information has been requested.