Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus flare) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Systemic lupus erythematosus disease flares after SARS- CoV- 2 vaccination. Arthritis Rheumatol; 73(9):1860-2. Concurrent medical conditions included Systemic lupus erythematosus. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus flare) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus flare) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Systemic lupus erythematosus (SLE) flare occurred in 12.5% of patients after receiving Moderna vaccine. Flare symptom was Fever, Joint pain, Joint swelling, Skin rash, Fatigue, muscle aches and other. Author reported that data suggest more than 91% of SLE patients did not experience a disease flare post- SARS-CoV-2 vaccination; of those that did, most had mild flares. Given almost all patients reported that their post- vaccine flares was "typical" of their SLE flares, vaccine side effects alone may not explain these findings. This information can help inform vaccine decision- making among patients with SLE. Future analyses will evaluate whether modifying immunosuppressive medications to enhance vaccine efficacy increased SLE flare risk. Concomitant and treatment medications were not reported. Company comment: This literature non-study case concerns multiple patients with concurrent condition of systemic lupus erythematosus (SLE), who experienced SLE flare up. Some of the patients experienced the event after both doses, whereas some of them developed the event after 1st or the 2nd dose exclusively. The flare up symptoms were usually mild, ''typical'' for their SLE flares, with symptoms of fever, joint pain and swelling, skin rash, fatigue, muscle aches among other. The benefit-risk relationship of mRNA-1273 was not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Upon internal review on 24-Mar-2022, a significant amendment was performed. Seriousness of event Systemic lupus erythematosus was corrected from non-serious to Medically significant. On 25-Feb-2022: Follow-up received by safety on 26-Feb-2022 included an Email received from Team contains significant information: Authors names; Sender's Comments: This literature non-study case concerns multiple patients with concurrent condition of systemic lupus erythematosus (SLE), who experienced SLE flare up. Some of the patients experienced the event after both doses, whereas some of them developed the event after 1st or the 2nd dose exclusively. The flare up symptoms were usually mild, ''typical'' for their SLE flares, with symptoms of fever, joint pain and swelling, skin rash, fatigue, muscle aches among other. The benefit-risk relationship of mRNA-1273 was not affected by this report.