Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Rheumatoid arthritis, Rheumatoid factor, Vaccination site pain
Clinical narrative: Diagnosed with shingles; Rheumatoid arthritis numbers were high; Left arm injection site was sore; Very tired for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high) and HERPES ZOSTER (Diagnosed with shingles) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SPIRONOLACTONE and VITAMINS NOS for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Left arm injection site was sore) and FATIGUE (Very tired for 2 days). On 23-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high) (seriousness criterion medically significant). On 04-Oct-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high), HERPES ZOSTER (Diagnosed with shingles) and VACCINATION SITE PAIN (Left arm injection site was sore) outcome was unknown and FATIGUE (Very tired for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Antibody test: positive (Positive) Sjogrens antibody was positive. On 22-Jun-2021, C-reactive protein: high (High) High. On 22-Jun-2021, Platelet count: high (High) High. On 22-Jun-2021, Red blood cell sedimentation rate: high (High) High. On 22-Jun-2021, Rheumatoid factor: high (High) Rheumatoid arthritis numbers were very high..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was diagnosed with shingles on 04-Oct-2021 by my dermatologist.  No treatment information was provided.  Company comment: This case concerns a 36-year-old female patient with relevant medical history of  Rheumatoid arthritis., who experienced the unexpected serious events of Rheumatoid arthritis and Herpes zoster .The event of Rheumatoid arthritis aggravated occurred approximately 1 month 10 days after the  second dose of Spikevax. The event of Herpes zoster occurred approximately 4 months 20 days after the  second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-340947 (Patient Link).; Sender's Comments: This case concerns a 36-year-old female patient with relevant medical history of  Rheumatoid arthritis., who experienced the unexpected serious events of Rheumatoid arthritis and Herpes zoster .The event of Rheumatoid arthritis aggravated occurred approximately 1 month 10 days after the  second dose of Spikevax. The event of Herpes zoster occurred approximately 4 months 20 days after the  second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.