Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Myocardial infarction, Oedema, Swelling
Clinical narrative: MULTIPLE STROKE; BLEEDING FROM BRAIN / BLOOD BURST; TWO HEART ATTACK; BLOOD CLOT / BLOOD CLOTS FORMING IN THE OTHER LEG; SEVERE EDEMA; CHEST SWELLING UP; WEIGHT LOSS OF 100 LBS; This spontaneous report received from a patient concerned an 62 year old, male. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered to left deltoid for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The patient took the product as directed. On an unspecified date, the patient reported that he was in the shower and started shaking, could not feel anything (paralysis) and was then hospitalized. He was then discharged from the hospital, and then later readmitted after being told that he had a stroke and was bleeding from the brain. The patient stated that he was paralyzed after receiving the vaccine and had a blood clot. He later mentioned that he was semi paralyzed since. He reported that when they took him to the emergency room, they said he had another stroke, blood burst, his head was bleeding. Paramedics took him, when he got there, his head was still bleeding and he had chest pain. Paramedics took him outside and the patient had a heart attack, then when they took him off of the gurney he had another heart attack, and had a second stroke. The patient reported that the blood clots forming in the other leg, chest swelling up, severe edema, and he was paralyzed more due to the second stroke and he could not even walk. The patient had both types of strokes and was severely paralyzed from it. The whole left side was paralyzed. The patient also mentioned that he had lost 100. lbs. It was not immediate, it was about a week after the booster. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital (dose number in series 2). Laboratory data (dates unspecified) included: Weight lost 100 lbs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple stroke, and the outcome of bleeding from brain / blood burst, blood clot / blood clots forming in the other leg, two heart attack, severe edema, weight loss of 100 lbs and chest swelling up was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230410374-multiple stroke, bleeding from brain / blood burst, two heart attack, severe edema, chest swelling up. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.  20230410374-blood clot / blood clots forming in the other leg. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.