Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram abdomen, Dehydration, Electrocardiogram, Feeling abnormal
Clinical narrative: Procedure for slight heart blockage; Passed out, Recurred passed out; RECURRENT OSTEOARTHRITIS ON RIGHT KNEE; IRREGULAR HEARTBEAT; LOWER BELLY CRAMPS; Chest pain; Sweaty; WHOLE BODY WAS KILLING; Head was hurting; COLITIS; CLOSTRIDIUM DIFFICILE; VEIN BLOCKAGE; DEHYDRATION; WORSENED JOINT PAINS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK (Procedure for slight heart blockage), LOSS OF CONSCIOUSNESS (Passed out, Recurred passed out), CLOSTRIDIUM DIFFICILE COLITIS (CLOSTRIDIUM DIFFICILE), VENOUS OCCLUSION (VEIN BLOCKAGE), DEHYDRATION (DEHYDRATION), COLITIS (COLITIS), OSTEOARTHRITIS (RECURRENT OSTEOARTHRITIS ON RIGHT KNEE), HEART RATE IRREGULAR (IRREGULAR HEARTBEAT), ABDOMINAL PAIN LOWER (LOWER BELLY CRAMPS), CHEST PAIN (Chest pain), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (WHOLE BODY WAS KILLING), ARTHRALGIA (WORSENED JOINT PAINS) and HEADACHE (Head was hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Cigarette smoker, Alcoholic and Gallbladder removal in September 2020. Concurrent medical conditions included Osteoarthritis since 2019, Rheumatoid arthritis since 2010, Depression, High cholesterol, Blood pressure high, Diabetes and Sulfonamide allergy. Concomitant products included LISINOPRIL for Blood pressure high, BUPROPION HYDROCHLORIDE (BUPROPION [BUPROPION HYDROCHLORIDE]), DULOXETINE and QUETIAPINE for Depression, SIMVASTATIN for High cholesterol, TIZANIDINE for Muscle spasm, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for Stomach cramps, MULTIVITAMINS & MINERALS PLUS LUTEIN for Supplementation therapy, PROBIOTIC 10, CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (WORSENED JOINT PAINS) (seriousness criterion hospitalization prolonged). On 13-May-2021, the patient experienced CLOSTRIDIUM DIFFICILE COLITIS (CLOSTRIDIUM DIFFICILE) (seriousness criteria hospitalization prolonged and medically significant) and COLITIS (COLITIS) (seriousness criterion hospitalization prolonged). In May 2021, the patient experienced VENOUS OCCLUSION (VEIN BLOCKAGE) (seriousness criterion hospitalization prolonged) and DEHYDRATION (DEHYDRATION) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ATRIOVENTRICULAR BLOCK (Procedure for slight heart blockage) (seriousness criterion hospitalization prolonged), LOSS OF CONSCIOUSNESS (Passed out, Recurred passed out) (seriousness criteria hospitalization prolonged and medically significant), OSTEOARTHRITIS (RECURRENT OSTEOARTHRITIS ON RIGHT KNEE) (seriousness criterion hospitalization prolonged), HEART RATE IRREGULAR (IRREGULAR HEARTBEAT) (seriousness criterion hospitalization prolonged), ABDOMINAL PAIN LOWER (LOWER BELLY CRAMPS) (seriousness criterion hospitalization prolonged), CHEST PAIN (Chest pain) (seriousness criterion hospitalization prolonged), HYPERHIDROSIS (Sweaty) (seriousness criterion hospitalization prolonged), FEELING ABNORMAL (WHOLE BODY WAS KILLING) (seriousness criterion hospitalization prolonged) and HEADACHE (Head was hurting) (seriousness criterion hospitalization prolonged). The patient was treated with POTASSIUM at an unspecified dose and frequency; VANCOMYCIN for Clostridium difficile colitis, at an unspecified dose and frequency; COLESTYRAMINE (QUESTRAN) for Diarrhea, at an unspecified dose and frequency; NITROGLYCERIN at an unspecified dose and frequency; LOPERAMIDE at an unspecified dose and frequency; GLUCOSE, POTASSIUM CITRATE, SODIUM CHLORIDE (PEDIALYTE 30) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ATRIOVENTRICULAR BLOCK (Procedure for slight heart blockage), VENOUS OCCLUSION (VEIN BLOCKAGE), COLITIS (COLITIS) and OSTEOARTHRITIS (RECURRENT OSTEOARTHRITIS ON RIGHT KNEE) had not resolved, LOSS OF CONSCIOUSNESS (Passed out, Recurred passed out) and CLOSTRIDIUM DIFFICILE COLITIS (CLOSTRIDIUM DIFFICILE) had resolved and DEHYDRATION (DEHYDRATION), HEART RATE IRREGULAR (IRREGULAR HEARTBEAT), ABDOMINAL PAIN LOWER (LOWER BELLY CRAMPS), CHEST PAIN (Chest pain), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (WHOLE BODY WAS KILLING), ARTHRALGIA (WORSENED JOINT PAINS) and HEADACHE (Head was hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Computerised tomogram: inconclusive (Inconclusive) UNNKNOWN. In October 2020, Ultrasound abdomen: inconclusive (Inconclusive) unknown. In October 2020, X-ray: inconclusive (Inconclusive) unknown. In March 2021, Stool analysis: negative (Negative) negative. In April 2021, Cardiac stress test: inconclusive (Inconclusive) unknown. In April 2021, Electrocardiogram: unknown (Inconclusive) UNKNOWN. On 04-May-2021, Colonoscopy: inconclusive (Inconclusive) UNKNOWN. In May 2021, Catheterisation cardiac: inconclusive (Inconclusive) UNKNOWN. On an unknown date, Clostridium test: inconclusive (Inconclusive) UNKNOWN. On an unknown date, Computerised tomogram abdomen: inconclusive (Inconclusive) unknown.         Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-102034, MOD-2021-102034 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.