Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Systemic lupus erythematosus, Vaccination site erythema, Vaccination site pain
Clinical narrative: SLE Flare; headache; pain at the injection site; redness at the injection site; Swelling 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 second 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), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and ARTHRALGIA (sore shoulder). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and ARTHRALGIA (sore shoulder) outcome was unknown. Related      For mRNA-1273 (Spikevax) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and ARTHRALGIA (sore shoulder) to be related.    No concomitant medications were reported. No treatment information was reported.  Company Comment:  This literature non-study case concerns a  patient with unknow 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 headache, vaccination site pain , vaccination site erythema , vaccination site swelling  and arthralgia.  These events occurred on an unknown date  after vaccination with the 2nd 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-2022-566431, US-MODERNATX, INC.-MOD-2022-566433 (Linked Report).; Sender's Comments: This literature non-study case concerns a  patient with unknow 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 headache, vaccination site pain , vaccination site erythema , vaccination site swelling  and arthralgia.  These events occurred on an unknown date  after vaccination with the 2nd 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  US-MODERNATX, INC.-MOD-2022-566417:Patient  US-MODERNATX, INC.-MOD-2022-566424:Patient  US-MODERNATX, INC.-MOD-2022-566426:Patient  US-MODERNATX, INC.-MOD-2022-566431:Patient  US-MODERNATX, INC.-MOD-2022-566433:Patient