Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmological examination normal, Paraesthesia, Pruritus, Puncture site pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Shingles; itching; tingling; burning; pin pricks; experiencing eye burning; feels like she's coming down with shingles; Herpes Zoster in her right eye; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In May 2020, the patient received the 2nd dose of Shingrix. In July 2019, unknown after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant), shingles, pruritus, tingling, burning sensation, puncture site pain and burning in eyes. The patient was treated with infliximab (Renflexis). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, herpes ophthalmic, rheumatoid arthritis, shingles, pruritus, tingling, burning sensation, puncture site pain and burning in eyes were unknown.   It was unknown if the reporter considered the vaccination failure, herpes ophthalmic, rheumatoid arthritis, shingles, pruritus, tingling, burning sensation, puncture site pain and burning in eyes to be related to Shingrix and Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received both doses of vaccine, had Rheumatoid Arthritis and had shingles twice a year before reporting. The patient received her second dose of Shingrix at the end of April or beginning of May 2020 and then restarted back on Renflexis 1 month later. The patient recently felt like she was coming down with shingles again. Her symptoms could be lingering from shingles last year. She had been experiencing itching, tingling and burning on the left side (trunk, abdomen and back) on and off since June and the biologic (Renflexis) did not seem to be working like it should. The patient had no rash. It felt like pin pricks.  These were the same type of symptoms she experienced last year but last year it was on the right side (shingles at end in July 2019 after getting Herpes Zoster in her right eye the month before). The patient was also experiencing eye burning on an off since a year before reporting. It was not continuous and not as intense as it was last year.  Her eye exam before her 2nd dose of Shingrix was clear. The patient asked if there were any evidence regarding interference between Shingrix and Biological Medications. After 1st dose patient waited aproximately 1 month (as per Physician´s advice) to take the biological medication, and 2nd dose was administered around May 2020. The health care professional reported having Rheumatoid Arthritis. The reporter consented to follow up. No further details were provided. This case was considered as suspected vaccination failure as details, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case was found to be duplicate of case US2020AMR148552, hence all the information from the case US2020AMR148552 would be added in the case US2020147985. Case US2020147985 was considered as case of record and Case US2020AMR148552 would be deleted from Agency core.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148552:same reporter