Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: SLE Flare; Headache; Itching; Rash at injection site; Redness at injection site; Swelling at injection site; 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), HEADACHE (Headache), PRURITUS (Itching), INJECTION SITE RASH (Rash at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE SWELLING (Swelling at injection site). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE Flare), HEADACHE (Headache), PRURITUS (Itching), INJECTION SITE RASH (Rash at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE SWELLING (Swelling at injection site) 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), HEADACHE (Headache), PRURITUS (Itching), INJECTION SITE RASH (Rash at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE SWELLING (Swelling at injection site) to be related.    Concomitant medications were not reported. Treatment information was not provided.  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 , unexpected event of pruritus , non-serious , expected events of headache,  injection site rash, injection site erythema  and injection site swelling.  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-2022-566426, US-MODERNATX, INC.-MOD-2022-566431, 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 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 , unexpected event of pruritus , non-serious , expected events of headache,  injection site rash, injection site erythema  and injection site swelling.  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-2022-566433:Patient 6 US-MODERNATX, INC.-MOD-2022-566431:Patient 5 US-MODERNATX, INC.-MOD-2022-566426:Patient 4 US-MODERNATX, INC.-MOD-2022-566446:Patient 7