Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest pain, Chills, Fatigue, Headache
Clinical narrative: LUPUS; Supraventricular tachycardia; Premature ventricular contractions; WORSENED BONE PAIN; low grade fever; chills; headache; Fatigue; CHEST PAIN; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (LUPUS) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient was non-illicit drug user.  Family history included Diabetes (MOTHER HAD DIABETES), CVA (MOTHER HAD CVA), Psoriatic arthritis (MOTHER HAD PSORIATIC ARTHRITIS), Hypertension (MOTHER HAD HYPERTENSION), Congestive heart failure (MOTHER HAD CHF), Kidney failure (MOTHER HAD KIDNEY FAILURE), Diabetes (FATHER HAD DIABETES), Hypertension (FATHER HAD HYPERTENSION) and Bladder cancer (FATHER HAD BLADDER CA). Concurrent medical conditions included Chest tightness, Non-tobacco user, Alcohol use (RARE/TWO TIMES PER MONTH), Drug allergy (VOLTAREN ALLERGY), Drug allergy (DILAUDID ALLERGY), Arrhythmia and Rheumatoid arthritis since 2017.   On 14-Apr-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced CHEST PAIN (CHEST PAIN). On 03-Feb-2021, the patient experienced BONE PAIN (WORSENED BONE PAIN), PYREXIA (low grade fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue). In May 2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Supraventricular tachycardia) and VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions). In November 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (LUPUS) (seriousness criterion medically significant). On 05-Feb-2021, PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (LUPUS), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular tachycardia) and VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) outcome was unknown, CHEST PAIN (CHEST PAIN) and FATIGUE (Fatigue) had not resolved and BONE PAIN (WORSENED BONE PAIN) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: UNSPECIFIED  UNK ABNORMAL LUPUS TEST.         No concomitant medications were reported.   The patient was treated with METOPROLOL.  On 02 Feb 2021, the patient experienced chest pain. on 03 Feb 2021, the patient experienced fatigue, chills, low grade fever, headache and worsened bone pain. on 05 Feb 2021, the chills, low grade fever and headache resolved. in May 2021, the patient experienced premature ventricular contractions and supraventricular tachycardia. in November 2021, the patient experienced medication induced/signs and symptoms of lupus.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Company comment: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of arrhythmia, chest tightness and rheumatoid arthritis on Adalimumab, who experienced the unexpected serious (medically significant) AESI Systemic lupus erythematosus, and unexpected non-serious AESIs Supraventricular tachycardia and Ventricular extrasystoles after receiving the 2nd dose of mRNA-1273 vaccine along with other non-serious events. Supraventricular tachycardia and Ventricular extrasystoles occurred approximately 3 months, and Systemic lupus erythematosus approximately 9 months post vaccination.  Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. It was reported after 1st dose, patient experienced arrhythmia, fatigue, chills, headache, fever, and vomiting. Rheumatoid arthritis, arrhythmia, and co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-165493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Significant follow-up appended(dose date, seriousness and events added) On 21-Jan-2022: Significant live follow up (Case narrative updated); Sender's Comments: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of arrhythmia, chest tightness and rheumatoid arthritis on Adalimumab, who experienced the unexpected serious (medically significant) AESI Systemic lupus erythematosus, and unexpected non-serious AESIs Supraventricular tachycardia and Ventricular extrasystoles after receiving the 2nd dose of mRNA-1273 vaccine along with other non-serious events. Supraventricular tachycardia and Ventricular extrasystoles occurred approximately 3 months, and Systemic lupus erythematosus approximately 9 months post vaccination.  Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. It was reported after 1st dose, patient experienced arrhythmia, fatigue, chills, headache, fever, and vomiting. Rheumatoid arthritis, arrhythmia, and co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.