Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Joint swelling, Systemic lupus erythematosus
Clinical narrative: Swollen joints; Painful joints; Systemic lupus erythematosus; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus), JOINT SWELLING (Swollen joints) and ARTHRALGIA (Painful joints) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Oct-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (Swollen joints) (seriousness criterion medically significant) and ARTHRALGIA (Painful joints) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) and JOINT SWELLING (Swollen joints) outcome was unknown and ARTHRALGIA (Painful joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2022, Blood test: Indicated might have lupus.         No concomitant medication information provided  On unknown date, the patient experienced joint problems with pain and stiffness in fingers, hands, wrists, elbows and hips, bump at injection site and patient had pen malfunction and the liquid squirted out with Humira (adalimumab). in 2022, the patient experienced patient might had lupus. In May 2022 the patient experienced rash on arms that got worsen in the sun. Since having Covid vaccinations the patient noticed joint problems with pain and stiffness in the fingers, hands, wrists, elbows and hips. For about two months from May 2022 the patient had a rash on the arms that got worse in the sun. The patient felt these issues had been caused by the Covid vaccinations. The patient had a pen malfunction and the liquid squirted out with HUMIRA. The patient had usually got a little bump on the injection site but did not had a bump on this injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Dose reported as Booster Dose.  No treatment medication information provided.  Company comment: This spontaneous case concerns a 64 year old male with concurrent Crohn's disease who experienced the unexpected serious (medically significant) event of Systemic Lupus Erythematosus, joint swelling and arthralgia which occurred at an unknown interval after receiving a dose of mRNA1273. The patient experienced joint problems with pain and stiffness in fingers, hands, wrists, elbows and hips and bump at the injection site. The patient also had a rash on the arms that got worse in the sun for about two months. The patient had an unspecified blood work which indicated lupus. Further details regarding the clinical course, other diagnostic test done and treatment were not provided. Information regarding prior COVID-19 vaccines were not mentioned. The patient's concurrent Crohn's disease may be contributory to the event joint swelling and arthralgia.  The benefit-risk relationship of mRNA-1273 vaccine is not affected   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 64 year old male with concurrent Crohn's disease who experienced the unexpected serious (medically significant) event of Systemic Lupus Erythematosus, joint swelling and arthralgia which occurred at an unknown interval after receiving a dose of mRNA1273. The patient experienced joint problems with pain and stiffness in fingers, hands, wrists, elbows and hips and bump at the injection site. The patient also had a rash on the arms that got worse in the sun for about two months. The patient had an unspecified blood work which indicated lupus. Further details regarding the clinical course, other diagnostic test done and treatment were not provided. Information regarding prior COVID-19 vaccines were not mentioned. The patient's concurrent Crohn's disease may be contributory to the event joint swelling and arthralgia.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.