Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Thrombosis
Clinical narrative: blood clots; leg pain due to clots; chills; diarrhea worse than when I had covid; chest pains; nerve sensations up and down back and arms; blood pressure went up; higher fever than when got covid; headaches; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020 and Thrombosis (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020. Concurrent medical conditions included Hypothyroidism, Blood pressure and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, HYDROCHLOROTHIAZIDE and METOPROLOL for Blood pressure, LEVOTHYROXINE for Hypothyroidism, POTASSIUM for Potassium, VITAMIN B NOS, VITAMIN D NOS and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, SAMBUCUS NIGRA (ELDERBERRY EXTRACT) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up), PYREXIA (higher fever than when got covid) and HEADACHE (headaches). On 15-May-2021, the patient experienced DIARRHOEA (diarrhea worse than when I had covid). In May 2021, the patient experienced CHEST PAIN (chest pains) and PARAESTHESIA (nerve sensations up and down back and arms). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain due to clots) and CHILLS (chills). On 16-May-2021, DIARRHOEA (diarrhea worse than when I had covid) had resolved. At the time of the report, THROMBOSIS (blood clots), CHEST PAIN (chest pains), PARAESTHESIA (nerve sensations up and down back and arms), BLOOD PRESSURE INCREASED (blood pressure went up), PAIN IN EXTREMITY (leg pain due to clots), PYREXIA (higher fever than when got covid), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.