Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sarcoidosis
Clinical narrative: Diagnosed with Sarcoidosis autoimmune disease after 2nd shot/Vaccine woke up the genetic autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of SARCOIDOSIS (Diagnosed with Sarcoidosis autoimmune disease after 2nd shot/Vaccine woke up the genetic autoimmune disease) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21 and 004F21A) for COVID-19 vaccination.     Family history included Scleroderma (Autoimmune) since an unknown date, MS since an unknown date and Autoimmune disorder since an unknown date.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced SARCOIDOSIS (Diagnosed with Sarcoidosis autoimmune disease after 2nd shot/Vaccine woke up the genetic autoimmune disease) (seriousness criterion medically significant). At the time of the report, SARCOIDOSIS (Diagnosed with Sarcoidosis autoimmune disease after 2nd shot/Vaccine woke up the genetic autoimmune disease) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.         Concomitant medications were not reported. Treatment medications included Steroids.  That night after 2nd dose, patient started coughing and felt really bad since then. Symptoms got worst in the next 2 weeks. Patient was taken to the emergency room. COVID test was negative. Now patient could hardly work. Patient had Extensive Nodular Swollen Lymph Nodes throughout the body. Diagnosis Sarcoidosis autoimmune disease.  The grandmother states that there was a genetic family history of autoimmune disease, MS and Scleroderma, but patient did not have any of that prior to vaccination. And stated that the vaccine woke up the genetic autoimmune disease in patient  Company comment: This spontaneous case concerns a 24-year-old male patient, with relevant family history of autoimmune disorder, multiple sclerosis and scleroderma, who experienced the serious (medically significant) unexpected event of Sarcoidosis. The event occurred on the same day after receiving a second dose of mRNA-1273 and has not yet resolved. The rechallenge is considered not applicable considering the outcome of the event and that no further dosing is expected. According to source document narrative, on the day of vaccination patient started to develop cough and lymphadenopathy that were later confirmed to be secondary to sarcoidosis. Patient is on unspecified steroid treatment. Patient's reported family history remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 24-year-old male patient, with relevant family history of autoimmune disorder, multiple sclerosis and scleroderma, who experienced the serious (medically significant) unexpected event of Sarcoidosis. The event occurred on the same day after receiving a second dose of mRNA-1273 and has not yet resolved. The rechallenge is considered not applicable considering the outcome of the event and that no further dosing is expected. According to source document narrative, on the day of vaccination patient started to develop cough and lymphadenopathy that were later confirmed to be secondary to sarcoidosis. Patient is on unspecified steroid treatment. Patient's reported family history remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.