Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lid sulcus deepened, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: she ends up bleeding; Swollen face; Sunken eyes; Couldn't speak; legs were cramping; burning legs; Blood clots on brain; Stroke; Blood clots on legs (left and right); stinging in leg; Fever; Diarrhea; Chills; Lower gut pain; Headache; back pain; Fall; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots on legs (left and right)), HAEMORRHAGE (she ends up bleeding), PYREXIA (Fever), DIARRHEA (Diarrhea), CHILLS (Chills), GASTROINTESTINAL PAIN (Lower gut pain), HEADACHE (Headache), PAIN IN EXTREMITY (stinging in leg), FALL (Fall), SWELLING FACE (Swollen face), LID SULCUS DEEPENED (Sunken eyes), APHASIA (Couldn't speak), BACK PAIN (back pain), MUSCLE SPASMS (legs were cramping), BURNING SENSATION (burning legs) and CEREBRAL THROMBOSIS (Blood clots on brain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high and Hysterectomy in 1981. Concurrent medical conditions included Penicillin allergy (penicillin allergy) and Drug allergy (Codeine allergy).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), GASTROINTESTINAL PAIN (Lower gut pain) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization) and BACK PAIN (back pain) (seriousness criterion hospitalization). On 11-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Blood clots on legs (left and right)) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (stinging in leg) (seriousness criterion hospitalization), MUSCLE SPASMS (legs were cramping) (seriousness criterion hospitalization), BURNING SENSATION (burning legs) (seriousness criterion hospitalization) and CEREBRAL THROMBOSIS (Blood clots on brain) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced FALL (Fall) (seriousness criterion hospitalization). In July 2021, the patient experienced SWELLING FACE (Swollen face) (seriousness criterion hospitalization), LID SULCUS DEEPENED (Sunken eyes) (seriousness criterion hospitalization) and APHASIA (Couldn't speak) (seriousness criterion hospitalization). On an unknown date, the patient experienced HAEMORRHAGE (she ends up bleeding) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (blood transfusion) for Thrombosis. The patient died on an unknown date. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, THROMBOSIS (Blood clots on legs (left and right)), HAEMORRHAGE (she ends up bleeding), PYREXIA (Fever), DIARRHOEA (Diarrhea), CHILLS (Chills), GASTROINTESTINAL PAIN (Lower gut pain), HEADACHE (Headache), PAIN IN EXTREMITY (stinging in leg), FALL (Fall), SWELLING FACE (Swollen face), LID SULCUS DEEPENED (Sunken eyes), APHASIA (Couldn't speak), BACK PAIN (back pain), MUSCLE SPASMS (legs were cramping), BURNING SENSATION (burning legs) and CEREBRAL THROMBOSIS (Blood clots on brain) outcome was unknown.            Patient was sent to the hospital that day and several tests were conducted like urine and Pet scan. No pulse on her legs as per husband and it also revealed that she had blood clots on both her left and right leg. She had 3 surgeries to take out the blood clot, however, she ended up bleeding. It got worse and hit her brain but fortunately, she did some therapy and after about 6 weeks, she was progressing well. Added that she fell three times in 2 days as per husband. Three weeks ago, he could not remember the exact date at around 7:15PM, he found his wife with swollen face, sunken eyes and couldn't speak. That day, he called 911 and was sent at the medical facility and was referred to a neurologist. They found out that she had massive blood clot on her brain that keeps on leaking and major stroke. She laid there for 3 days and the doctor told the husband that brain scan showed worst results and so they decided to remove her breathing tool and or extubated. She lasted for about 12 hours and died.  No concomitant drugs were provided.  Company comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Stroke