Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hepatic enzyme, Injection site papule, Injection site pruritus, Laboratory test
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hearing loss in 2011, Joint pain (Ankle pain, Elbow pain, Shoulder pain, Fingers pain, Toes and feet pain) in 2011, Psoriasis, Dry eyes, Dry mouth, Lupus erythematosus, Arthroscopic surgery in 1988, Anterior cruciate ligament reconstruction, Mid-urethral sling procedure in 2014, Uterine ablation in 2014, Foot surgery in 1984, Appendectomy in 1992 and Caesarean section in 1998. Previously administered products included for Psoriatic arthritis: METHOTREXATE; for Plaque psoriasis: METHOTREXATE. Past adverse reactions to the above products included No adverse event with METHOTREXATE and METHOTREXATE. Family history included Lupus erythematosus. Concurrent medical conditions included Psoriatic arthritis, Fibromyalgia, Pain in jaw, Back pain and Oesophagitis. Concomitant products included LISINOPRIL for Blood pressure high, ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis, METHOTREXATE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced FIBROMYALGIA (Fibromyalgia). In April 2021, the patient experienced VACCINATION SITE PAIN (Injection site stinging). In May 2021, the patient experienced HEART RATE INCREASED (Heart rate increased). In 2021, the patient experienced GASTRITIS (Stomach inflammation). In July 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE PAPULE (Injection site papule). On 20-Aug-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) (seriousness criterion medically significant). The patient was treated with OMEPRAZOLE ongoing since an unknown date for Acid reflux (esophageal), at an unspecified dose and frequency and CELECOXIB (CELEBREX) for Foot pain, at an unspecified dose and frequency. In April 2021, VACCINATION SITE PAIN (Injection site stinging) had resolved. In July 2021, INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE PAPULE (Injection site papule) had not resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) and HEART RATE INCREASED (Heart rate increased) had not resolved, GASTRITIS (Stomach inflammation) had resolved and FIBROMYALGIA (Fibromyalgia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Colonoscopy: everything was fine. In February 2021, Endoscopy: Inflammation of polyp, polyp in stomach. On 09-Apr-2021, Blood test: Confirmed elevated liver enzymes. On 09-Apr-2021, Laboratory test: Negative for Sjogren's syndrome. On 25-Jun-2021, Endoscopy: Removed gastric polyp in stomach. On 20-Aug-2021, X-ray: Confirmed significant misalignment in her neck and systemic lupus. On 20-Aug-2021, X-ray of pelvis and hip: Confirmed arthritis on the pubic bone. On an unknown date, Endoscopy: inflammation in her esophagus and stomach. On an unknown date, Hepatic enzyme: Increased. On an unknown date, Magnetic resonance imaging: NECK MRI: disc in her neck that is out of alignment. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was on a keto diet and tested negative for Sjogren's syndrome. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. On 31 Mar 2021, she received second dose COVID-19 Vaccine manufactured by Moderna, lot number unknown, expiration date unknown. The last time she donated blood, her heart rate was fast around 100. She had been monitoring this since May 2021. She developed severe foot pain while travelling. She took Celebrex and it helped. She did not want to stop taking Humira because it was helped her so much. She also declined to start taking medication to help with lupus symptoms. As of 23 Aug 2021, she still had swelling in her joints but no redness. She had good days and bad days but did woke up stiff in the morning. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In -Jul-2021 that last for four to five days she had a raised and itchiness on injection site on some instances of taking Humira. On 08-Jul-2021 she visit the neurosurgeon and discussed magnetic resonance imaging results. Patient saw chiropractor once every five weeks to re-align the neck last 20-Jul-2021. On 08-Jul-2021 she had therapy for degeneration on her neck. Going to the chiropractor somehow resolves most symptoms but those symptoms came back after every session. She wanted to stay with Humira despite dermatologist thought the Lupus was probably caused by taking Humira. On 27 Aug 2021 she had joint pain and was sore after doing vigorous exercise for a day and a half or sometimes last for two days. She had endoscopy to stretch out the esophagus to address dry throat and cough. Patient had body ache and joints were stiff that started the next day after the Covid 19 vaccine administration and last for two to three days. Primary reporter does not have the expiration date of CoVid-19. This case was linked to MOD-2021-624908 (Patient Link). The symptoms Joint swelling and Arthralgia were subsumed under Systemic lupus erythematosus. The symptoms Back pain and Pain were subsumed under Fibromyalgia. The symptom Dyspepsia under Gastritis. 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 female patient aged 51 years with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Systemic lupus erythematosus 142 days after second dose of mRNA-1273 vaccine. Patient had received first dose 28 days prior to current vaccination. Patient also experienced non serious events of Fibromyalgia, vaccination site pain and injection site pruritis, gastritis. She visited her physician and had extensive blood work and x rays done. Hepatic enzyme test done was increased. Her physician diagnosed her with lupus and fibromyalgia. She experienced random symptoms that may be associated with her new diagnosis of lupus and fibromyalgia. Her physician thought it may be related to taking Humira. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant Follow-up received included medical history added, lab data added, suspected details and treatment medication updated, events added, narrative updated. Sender's Comments: This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Systemic lupus erythematosus 142 days after second dose of mRNA-1273 vaccine. Patient had received first dose 28 days prior to current vaccination. Patient also experienced non serious events of Fibromyalgia, vaccination site pain and injection site pruritis, gastritis. She visited her physician and had extensive blood work and x-rays done. Hepatic enzyme test done was increased. Her physician diagnosed her with lupus and fibromyalgia. She experienced random symptoms that may be associated with her new diagnosis of lupus and fibromyalgia. Her physician thought it may be related to taking Humira. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.