Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: diagnosed with Lupus; diagnosed with RA; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed with Lupus) and RHEUMATOID ARTHRITIS (diagnosed with RA) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Abdominal discomfort (Was being treated for stomach issues.  Recent change in status improvement or worsening unknown) since 2019, GERD (Recent change in status such as improvement or worsening - unknown) since 2019, Hiatal hernia (Recent change in status such as improvement or worsening - unknown) since 2019, Food allergy (Allergic to Mushroom), Food allergy (Allergic to Gluten) and Seasonal allergy. Concomitant products included VITAMINS NOS, PROBIOTICS NOS, TOCILIZUMAB (ACTEMRA), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CELECOXIB (CELEBREX), PREDNISONE and METHOTREXATE for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed with Lupus) (seriousness criteria hospitalization and medically significant) and RHEUMATOID ARTHRITIS (diagnosed with RA) (seriousness criteria hospitalization and medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed with Lupus) and RHEUMATOID ARTHRITIS (diagnosed with RA) had not resolved.            Medical History: History related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concomitant products included Supplements for stomach/gut health , Actemra had an allergic reaction but no longer on and patient was on Prednisone for 8 1/2 to 9 months and no longer on. In July referred to a Rheumatologist for bloodwork. It was reported that patient Never been tested for COVID positive and never felt any symptoms. Reporter stated they were a healthy person prior to getting this vaccine, now they are just a "sick person Treatment details was not reported by the reporter. Company comment This spontaneous case reported by a consumer concerns a 64-year-old, female patient with relevant medical history reported as relating to the mentioned Adverse Events with both Acute and Chronic illnesses at the time of vaccination and taking concomitant medications with Tocilizumab, Hydroxychloroquine,  Celecoxib,  prednisone and methotrexate, experienced the unexpected serious (Hospitalization, Medically significant) AESI events of Systemic Lupus Erythematosus and Rheumatoid Arthritis, approximately about 2 months (date on onset of the events is not provided) after the second dose of mRNA 1273 Vaccine. Patient had the first dose of mRNA-1273 on 22 March 2022. It was reported that the pain happened about 10-12 days after first vaccine. Reporter stated that the movements were difficult all day long with  extreme pain and from her neck down to her fingers she could not move. she was in horrible pain for many months. Towards the end of April she was suspected to have Polymyalgia Rheumatica (PMR). Physician prescribed her prednisone and referred to a Rheumatologist for bloodwork and was diagnosed with Lupus and RA in July 2021. Patient's undisclosed past medical history relating to the mentioned Adverse Events with acute and chronic illness could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-529262, MOD-2022-528982 (Patient Link).; Sender's Comments: This spontaneous case reported by a consumer concerns a 64-year-old, female patient with relevant medical history reported as relating to the mentioned Adverse Events with both Acute and Chronic illnesses at the time of vaccination and taking concomitant medications with Tocilizumab, Hydroxychloroquine,  Celecoxib,  prednisone and methotrexate, experienced the unexpected serious (Hospitalization, Medically significant) AESI events of Systemic Lupus Erythematosus and Rheumatoid Arthritis, approximately about 2 months (date on onset of the events is not provided) after the second dose of mRNA 1273 Vaccine. Patient had the first dose of mRNA1273 on 22 March 2022. It was reported that the pain happened about 10-12 days after first vaccine. Reporter stated that the movements were difficult all day long with  extreme pain and from her neck down to her fingers she could not move. she was in horrible pain for many months. Towards the end of April she was suspected to have Polymyalgia Rheumatica (PMR). Physician prescribed her prednisone and referred to a Rheumatologist for bloodwork and was diagnosed with Lupus and RA in July 2021. Patient's undisclosed past medical history relating to the mentioned Adverse Events with acute and chronic illness could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.