Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Eye irritation, Thrombosis
Clinical narrative: Beginning of a blood clot in the middle of the left calf muscle; Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included FEXOFENADINE for Allergy, ALBUTEROL SULFATE for Asthma, PARACETAMOL (TYLENOL) for Migraine, TIZANIDINE, ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM CHLORIDE, VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], MINERALS NOS, COLECALCIFEROL (VITAMIN D3), GABAPENTIN, PRIMIDONE, RANITIDINE, CLOPIDOGREL, BUTALBITAL, CAFFEINE, MELATONIN, TERAZOSIN, ZINC, FINASTERIDE, MONTELUKAST, LUBIPROSTONE (AMITIZA), TAMSULOSIN, SIMVASTATIN, ATENOLOL, CHLORTALIDONE, PANTOPRAZOLE, MIRABEGRON (MYRBETRIQ), POLYETHYLENE GLYCOL [MACROGOL], FENOFIBRATE, SODIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MILK OF MAGNESIA), SULFADIAZINE SILVER (SILVER SULFADIAZINE) and FLUTICASONE for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 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 experienced THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) (seriousness criterion medically significant), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea). At the time of the report, THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient normally stays with diarrhea because takes double of the normal amount of the polyethylene glycol daily, takes 17 grams twice a day. And there is the beginning of a blood clot in the middle of the left calf muscle which may be related to his COPD, but he had to see a doctor about it.  Treatment information was not provided.  Company comment: 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. Limited information regarding the event Thrombosis have been provided. Further information has been request.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.   This case was linked to MOD-2021-163528 (Patient Link).; 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. Limited information regarding the event Thrombosis have been provided. Further information has been request.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.