Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Colitis, Coronary artery occlusion, Crohn's disease, Dehydration
Clinical narrative: Passed out; Coronary occlusion; Clostridium difficile infection; Dehydration; Chest pain; Recurrent diarrhea; Colitis; stomach cramping after gallbladder removal; Gallstones; Recurrent osteoarthritis in right knee; Post procedural complication; Unevaluable event; Crohn's disease; worsened joint pain; Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), CORONARY ARTERY OCCLUSION (Coronary occlusion), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection), DEHYDRATION (Dehydration), CHEST PAIN (Chest pain), DIARRHOEA (Recurrent diarrhea), COLITIS (Colitis), CROHN'S DISEASE (Crohn's disease) and ABDOMINAL PAIN UPPER (stomach cramping after gallbladder removal) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Alcohol use (Five bottles of beer during the week was consumed by the patient since 1979), Tobacco user (10 cigarettes per day since 1977) and Gallbladder removal in October 2020. Concurrent medical conditions included Osteoarthritis since 2019, Rheumatoid arthritis (Rheumatoid arthritis in lower extremities since 2019) since 2019, Depression, High cholesterol, Blood pressure high, Diabetes, Drug allergy (Sulfa drugs allergy) and Rheumatoid arthritis since 2019. Concomitant products included LISINOPRIL for Blood pressure high, BUPROPION, DULOXETINE and QUETIAPINE for Depression, SIMVASTATIN for High cholesterol, TIZANIDINE for Muscle spasm, DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]) for Stomach cramps, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE MONONITRATE;TOCOPHERYL ACETATE] for Vitamin supplementation, PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS], CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ETANERCEPT (ENBREL) for an unknown indication.   On 01-Sep-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (worsened joint pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), CORONARY ARTERY OCCLUSION (Coronary occlusion) (seriousness criteria hospitalization and medically significant), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) (seriousness criteria hospitalization and medically significant), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DIARRHOEA (Recurrent diarrhea) (seriousness criterion hospitalization), COLITIS (Colitis) (seriousness criterion hospitalization), CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach cramping after gallbladder removal) (seriousness criterion hospitalization), CHOLELITHIASIS (Gallstones), OSTEOARTHRITIS (Recurrent osteoarthritis in right knee), POST PROCEDURAL COMPLICATION (Post procedural complication) and UNEVALUABLE EVENT (Unevaluable event). The patient was treated with POTASSIUM at a dose of UNK dosage form; NITROGLYCERIN at a dose of UNK dosage form; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form; LOPERAMIDE at a dose of UNK dosage form; VANCOMYCIN at a dose of UNK dosage form; CALCIUM CHLORIDE, GLUCOSE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE (PEDIALYTE [CALCIUM CHLORIDE;GLUCOSE;MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE;SODIUM CHLORIDE;SODIUM LACTATE]) at a dose of UNK dosage form and COLESTYRAMINE (QUESTRAN) at a dose of UNK dosage form. On 28-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) and DIARRHOEA (Recurrent diarrhea) had resolved, CORONARY ARTERY OCCLUSION (Coronary occlusion), COLITIS (Colitis), ABDOMINAL PAIN UPPER (stomach cramping after gallbladder removal), CHOLELITHIASIS (Gallstones), OSTEOARTHRITIS (Recurrent osteoarthritis in right knee), POST PROCEDURAL COMPLICATION (Post procedural complication), UNEVALUABLE EVENT (Unevaluable event) and ARTHRALGIA (worsened joint pain) had not resolved, DEHYDRATION (Dehydration) and CHEST PAIN (Chest pain) was resolving and CROHN'S DISEASE (Crohn's disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Stool analysis: (Positive) Clostridium difficile infection. In April 2021, Cardiac stress test: (Inconclusive) unknown. In April 2021, Electrocardiogram: irregular heart beats.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Follow up received on 21-May-2021 included second dose of covid-19 administration on 24-Apr-2021. new events which included loss of consciousness, irregular heart beats, coronary occlusion, unevaluable event, dehydration, chest pain, colitis, arthralgia aggravated, outcome of events, concomitant and treatment medications.  Past medication included Enbrel (etanercept) for unknown indication.  In Oct 2020, after having her gallbladder removed the patient experienced diarrhea which worsened and stomach cramping.  Her gastrointestinal physician thought that she had Crohns disease but there was no diagnostic test done.  She called her physician in Mar 2021 to report her recurrent diarrhea for six months. Stool examination done revealed clostridium difficile infection and she was treated with questran and vancomycin. It was reported that on an unspecified date, she also had a stress test for irregular heartbeats. She was hospitalized for catheterization procedure because her stress test and EKG were not normal. She did not require a stent. She was also treated for dehydration and treatment included intravenous fluids and potassium. Colonoscopy was also done during hospitalization and the patient was told she had colitis.   This case was linked to MOD-2021-162644 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21 May 2021 included additional events, concomitant medications, hospitalization details, treatment medication, second dose administration and outcome of event. On 21-May-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.