Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fibromyalgia, Headache, Illness, Impaired work ability
Clinical narrative: Lupus; Fibromyalgia; Sleep apnea; Have been sick; Diarrhea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).; Extreme weakness; Wasn't able to get out of bed; General body ache; Fatigue; Vomiting/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).; Nausea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).; Chills; Slight headache; Began to Interfere with my ablity to function normally in august 2021; Brain fog which started in late june of 2021; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A. and 026A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol in 2000, Depression (Moderate) in 1985, Fibromyalgia in 1993, Autoimmune disorder (lupus father autoimmune) in October 2021 and Sleep apnea from 11-May-2019 to 19-Oct-2021. Previously administered products included for Product used for unknown indication: Influenza (manufacturer:quadrivalent, routeinjection and on left arm dose number 1-1) on 12-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Influenza. Concurrent medical conditions included Autoimmune disorder NOS, Drug allergy (Morphine), Drug allergy (Fosamax), Drug allergy (Glucosamine), Drug allergy (condrotin), Allergy to antibiotic (Cefdinir) and Blood pressure high since 1996. Concomitant products included AMLODIPINE, METOPROLOL, LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], MULTIVITAMINS [VITAMINS NOS], LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), BUSPIRONE HYDROCHLORIDE (BUSPAR), CALCIUM, VITAMIN K NOS, VITAMIN D NOS, PRAVASTATIN, CELECOXIB (CELEBREX) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (Brain fog which started in late june of 2021). In August 2021, the patient experienced ILLNESS (Have been sick), DIARRHOEA (Diarrhea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), ASTHENIA (Extreme weakness), BEDRIDDEN (Wasn't able to get out of bed), IMPAIRED WORK ABILITY (Began to Interfere with my ablity to function normally in august 2021), MYALGIA (General body ache), FATIGUE (Fatigue), VOMITING (Vomiting/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), NAUSEA (Nausea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), CHILLS (Chills) and HEADACHE (Slight headache). In October 2021, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) (seriousness criterion medically significant) and FIBROMYALGIA (Fibromyalgia). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhoea, at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus), FEELING ABNORMAL (Brain fog which started in late june of 2021), IMPAIRED WORK ABILITY (Began to Interfere with my ablity to function normally in august 2021), FIBROMYALGIA (Fibromyalgia) and MYALGIA (General body ache) outcome was unknown and SLEEP APNOEA SYNDROME (Sleep apnea), ILLNESS (Have been sick), DIARRHOEA (Diarrhea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), ASTHENIA (Extreme weakness), BEDRIDDEN (Wasn't able to get out of bed), FATIGUE (Fatigue), VOMITING (Vomiting/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), NAUSEA (Nausea/In early aug 2021, started having on/off bouts of nausea/vomiting and diarrhea, at first they were mild but grew more intense  and occured more often (3x or more per week).), CHILLS (Chills) and HEADACHE (Slight headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Sleep study: abnormal (abnormal) the result is abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient race information is reported as black. Patient had very very shot vault of diarrhea for 10 minutes and in Aug 2021 again patient had diarrhea.Took Imodium but it didn't work. On 03-Nov-2021Patient has taken booster dose on 03-Nov-2021. On August 2021 patient suffered form headache,sneezing, runny/stuffy nose, brain fog, vomiting, diarrhea, fatigue, chills which is still ongoing till the time of vaccination and upto on month befor vaccination  by the end of august she could not take it anymore and made an appointment with the doctor on September 4,2021patient went through battery of sens/tests/blood work. patient is on CPAP and the headache is less sever, she is back to on /off pattern and experienced in early august. On 23-sep-2021 patient underwent tests: Anachoice(R) specific abscading reflex, the result was abnormal rheumatoid factor,vitaamin D 25 hydroxy, lipid panel,CRP(Acutr phase), comprehensive metabolic panel, CBC W/ AUTO differential, TSH reflex to Free T4, TIER1,RNP antibody interpretation- the result was abnormal, CT HEAD WO contrast,  Company comment This case concerns a 68 year-old female patient with a family history of lupus autoimmune disease and a personal history of fibromyalgia, multiple drug hypersensitivities, and influenza vaccine in October 2021 who experienced the unexpected serious event of systemic lupus erythematosus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The family medical history of lupus autoimmune disease remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-390918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received and contains no new information. On 23-Nov-2021: Significant FU: REPORTER informatin added HCP added, patient demographic details added, medical history added, allergic condition added, concomitants provided, additional events added, lab test data provided, case upgraded to serious.; Sender's Comments: This case concerns a 68 year-old female patient with a family history of lupus autoimmune disease and a personal history of fibromyalgia, multiple drug hypersensitivities, and influenza vaccine in October 2021 who experienced the unexpected serious event of systemic lupus erythematosus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The family medical history of lupus autoimmune disease remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.