Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Systemic lupus erythematosus, Vaccination site pain
Clinical narrative: SLE Flare; pain at the injection site; sore shoulder; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Systemic lupus erythematosus.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare) (seriousness criterion medically significant), VACCINATION SITE PAIN (pain at the injection site) and ARTHRALGIA (sore shoulder). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare), VACCINATION SITE PAIN (pain at the injection site) and ARTHRALGIA (sore shoulder) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare), VACCINATION SITE PAIN (pain at the injection site) and ARTHRALGIA (sore shoulder) to be related.    Concomitant and treatment medications were not reported.  Company Comment: This literature non-study case concerns a patient with unknown age and gender with relevant medical history of Systemic lupus erythematosus, who experienced Serious (medically significant), unexpected, event of  Systemic lupus erythematosus (SLE flare) and non-serious, expected events of vaccination site pain and arthralgia. These events occurred on an unknown date after vaccination with the 1st dose of mRNA-1273 vaccine (date of vaccination also not reported). The details surrounding the events were not reported since the full text of this literature for review is not available. Outcome of all of the events was reported as unknown. The events were reported as related by the reporter. The benefit -risk relationship of mRNA-1273 (Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review.   This case was linked to US-MODERNATX, INC.-MOD-2022-496261, US-MODERNATX, INC.-MOD-2022-566417, US-MODERNATX, INC.-MOD-2022-566424, US-MODERNATX, INC.-MOD-2022-566426, US-MODERNATX, INC.-MOD-2022-566433, US-MODERNATX, INC.-MOD-2022-566446 (Linked Report).; Sender's Comments: This literature non-study case concerns a patient with unknown age and gender with relevant medical history of Systemic lupus erythematosus, who experienced Serious (medically significant), unexpected, event of  Systemic lupus erythematosus (SLE flare) and non-serious, expected events of vaccination site pain and arthralgia. These events occurred on an unknown date after vaccination with the 1st dose of mRNA-1273 vaccine (date of vaccination also not reported). The details surrounding the events were not reported since the full text of this literature for review is not available. Outcome of all of the events was reported as unknown. The events were reported as related by the reporter. The benefit -risk relationship of mRNA-1273 (Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review. US-MODERNATX, INC.-MOD-2022-496261:Patient 1 US-MODERNATX, INC.-MOD-2022-566417:Patient 2 US-MODERNATX, INC.-MOD-2022-566424:Patient 3 US-MODERNATX, INC.-MOD-2022-566426:Patient 4 US-MODERNATX, INC.-MOD-2022-566433:Patient 6 US-MODERNATX, INC.-MOD-2022-566446:Patient 7