Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: Had covid at the end of January,2022 and developed into covid Pneumonia; Lack of drug effect; Diagnosed with lupus in November,2021; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with lupus in November,2021) and COVID-19 PNEUMONIA (Had covid at the end of January,2022 and developed into covid Pneumonia) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetic and Shellfish allergy.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with lupus in November,2021) (seriousness criterion medically significant). On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced COVID-19 PNEUMONIA (Had covid at the end of January,2022 and developed into covid Pneumonia) (seriousness criterion medically significant). In February 2022, COVID-19 PNEUMONIA (Had covid at the end of January,2022 and developed into covid Pneumonia) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with lupus in November,2021) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient had covid end of January, tested positive on 24Jan2022 and developed into covid Pneumonia and lasted till middle of February,2022.  Company comment: This spontaneous case concerns a 58-year-old female patient, with relevant medical history of Hypertension, Diabetic, who experienced the unexpected serious (medically significant) events Systemic lupus erythematosus and Covid-19 Pneumonia (AESI), on an unspecified date approximately four months and six months later respectively after second dose of mRNA-1273. Additionally, vaccine ineffective was also reported. The patient experienced, lupus, Covid, and on a later date, Pneumonia. SARS-CoV-2 test was positive. Systemic lupus erythematosus could be causative for the patient's hypertension and diabetes. Current pandemic situation of Covid-19 could be a confounder for Covid-19 Pneumonia. At the time of reporting, Covid-19 Pneumonia had resolved, and outcome of Systemic lupus erythematosus was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527036.; Sender's Comments: This spontaneous case concerns a 58-year-old female patient, with relevant medical history of Hypertension, Diabetic, who experienced the unexpected serious (medically significant) events Systemic lupus erythematosus and Covid-19 Pneumonia (AESI), on an unspecified date approximately four months and six months later respectively after second dose of mRNA-1273. Additionally, vaccine ineffective was also reported. The patient experienced, lupus, Covid, and on a later date, Pneumonia. SARS-CoV-2 test was positive. Systemic lupus erythematosus could be causative for the patient's hypertension and diabetes. Current pandemic situation of Covid-19 could be a confounder for Covid-19 Pneumonia. At the time of reporting, Covid-19 Pneumonia had resolved, and outcome of Systemic lupus erythematosus was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.