Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Gait disturbance, Loss of consciousness, Peripheral swelling
Clinical narrative: having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen; she almost died; urinary tract infection; right leg is very swollen; Kept losing consciousness/Passed out; hard time walking; had to use a walker; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen), LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) and FEELING ABNORMAL (she almost died) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 004m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOFLOXACIN, RIVAROXABAN (XARELTO), LISINOPRIL, HYDROCHLOROTHIAZIDE, OXYCODONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced GAIT DISTURBANCE (hard time walking) and WALKING AID USER (had to use a walker). On 12-Apr-2021, the patient experienced THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen) (seriousness criteria hospitalization prolonged, medically significant, life threatening and intervention required) and LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) (seriousness criterion medically significant). 12-Apr-2021, the patient experienced FEELING ABNORMAL (she almost died) (seriousness criteria hospitalization and medically significant). On 26-Apr-2021, the patient experienced PERIPHERAL SWELLING (right leg is very swollen). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was hospitalized from 12-Apr-2021 to 19-Apr-2021 due to FEELING ABNORMAL and THROMBOSIS. On 12-Apr-2021, LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) had resolved. At the time of the report, THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen) was resolving and FEELING ABNORMAL (she almost died), URINARY TRACT INFECTION (urinary tract infection), GAIT DISTURBANCE (hard time walking), PERIPHERAL SWELLING (right leg is very swollen) and WALKING AID USER (had to use a walker) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: blood clots (abnormal) blood clot. On 12-Apr-2021, Ultrasound scan: blood clots (abnormal) blood clots.         Action taken with mRNA-1273 in response to the events was not applicable. Patient stated she was in the ICU24-48 hours then transferred to another area of the hospital where she spent another 5-6days. She is still having to use a walker. Her right leg is very swollen. She has to walk and keep her right leg elevated.  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. However, Further information has been requested.   This case was linked to MOD-2021-090647 (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 event, a causal relationship cannot be excluded. However, Further information has been requested.