Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Rheumatic disorder, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Rheumatoid arthritis flare up; Rheumatic disorder; Condition agrravated; Rheumatic disorder; Condition agrravated; This case was reported in a literature article and described the occurrence of rheumatoid arthritis flare up in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis and rheumatic disorder.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), rheumatoid arthritis flare up (serious criteria GSK medically significant), rheumatic disorder, condition aggravated, rheumatic disorder and condition aggravated. On an unknown date, the outcome of the rheumatoid arthritis flare up, rheumatic disorder and condition aggravated were recovered/resolved and the outcome of the rheumatoid arthritis flare up, rheumatic disorder and condition aggravated were unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up, rheumatic disorder and condition aggravated to be related to Shingles vaccine. It was unknown if the reporter considered the rheumatoid arthritis flare up, rheumatic disorder and condition aggravated to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of flare (RA flare-up or SRD flare-up) in a patient of unspecified age and gender, who was vaccinated with unspecified zoster recombinant adjuvanted (ZRA) vaccine (manufacturer unknown) for prophylaxis. The objective of the study was patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). In this study, it was investigated the impact of the zoster recombinant adjuvanted (ZRA) vaccine in patients with RA and SRD and measured the incidence of flares and side effects. [It was performed a retrospective chart review of all patients with RA and SRD who received at least one dose of ZRA from February 1, 2018 to February 1, 2019]. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date between 1 February 2018 and 1 February 2019, the patient received 2 doses of unspecified zoster recombinant adjuvanted vaccine (administration route and site unspecified; batch number not provided). The age of vaccination was not provided. [Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. A live attenuated vaccine was approved by the Food and Drug Administration (FDA) for HZ prevention in 2006 for adults age 60 or older. ZRA is a two-dose series, with doses given two to six months apart]. On an unspecified date, 2 months after the vaccination, the patient experienced a flare (RA flare-up or SRD flare-up). [A flare was defined as occurring within 12 weeks of the ZRA administration by either 1) documentation of an RA or SRD flare in the rheumatologist's office notes, telephone encounter, or patient portal communication, or 2) a new corticosteroid prescription or an increase in the dose of a preexisting corticosteroid prescription. An outbreak of HZ was defined as 1) documentation of HZ in the electronic medical record, including visits to the emergency department, office notes, telephone encounters, patient portal communications, or 2) a prescription for antiviral therapy (i.e., valacyclovir). Flares were identified in 27 (6.7%) individual patients (an incidence rate of 6.7 cases per 100 patient-years), with 23 (5.7%) flares occurring after the first dose and 5 (2.3%) flares occurring after the second. One patient experienced a flare following both doses. Nineteen (5.0%) flares were identified in patients with RA, and nine (3.6%) flares were identified in patients with an SRD]. Treatment was unknown. The outcome of the event was not reported. The author commented, "Immunosuppressant medications used to treat rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) (corticosteroids, methotrexate, biologic disease-modifying agents, and janus kinase inhibitors) can increase the incidence of HZ. In our experience of 403 rheumatology patients (239 patients with RA and 164 patients with an SRD) who received the ZRA vaccine, the incidence of flares among all patients was less than 7%. Because of the national shortage of ZRA during the study period, just over half of the patients (222 [55.1%]) received the second vaccine, and not all patients received the vaccine within the recommended 2- to 6-month time frame. In clinical trials of ZRA, the clinical efficacy was defined as a reduced incidence in the occurrence of zoster in more than 90% of people. The incidence rate of HZ in our population was 0.7%, which is not higher than that observed in the clinical studies. Three (0.7%) cases of HZ were reported, and these occurred 2, 10, and 11 months following vaccine administration. One patient was taking mycophenolate mofetil, and two of the patients were taking tofacitinib, which has been associated with an increased risk of zoster. Both tofacitinib and tocilizumab have been shown be associated with an increased incidence of HZ. In a study comprised of 2500 subjects initiating tofacitinib compared with 67,200 subjects initiating other biologics, the rate of HZ was twice as high in patients taking tofacitinib than in patients taking other biologic medicines. We also did not evaluate the immune response to the vaccine following administration. Previous studies report that immunosuppressive therapies commonly used to treat patients with RA and SRD may reduce the vaccine response. Further studies are needed to examine the effectiveness and durability of the HZ vaccine in rheumatology patients who are immunocompromised." The author concluded, "In 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials. Based on our results, we encourage the use of the ZRA vaccine in patients with RA and other SRDs treated with immunosuppressive therapies." This article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 4 valid cases reported in the same literature article.