Reporte zur Charge LOT: 1808980

Symptomtext

BLOOD CLOT IN RIGHT CALF; BLOOD CLOT IN LEFT LUNG; COULDN'T WALK; FATIGUED WHEN WALKING; MUSCLE PAIN; WALKING SLOW / STUMBLING; LEFT CALF PAIN; This spontaneous report received from a consumer concerned a 40-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980 00040604, expiry: not reported) dose was not reported,1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. In APR-2021, about a week after vaccination, the patient experienced right calf pain/right lower leg pain and muscle pain. Patient was unable to walk, experienced fatigue while walking and was out of breath/unable to breath and on 20-APR-2021, the patient went to the urgent care (Emergency room) and then to the hospital. At hospital, patient had done Ultrasound Test and found blood clot in right calf (right leg) and in left lung. Patient was unable to breath. At hospital, patient was given with medication for blood clotting. After taking medication, patient was able to take breath. On 21-APR-2021, patient was discharged from hospital with medication to prevent blood clotting. Patient was hospitalized for 2 days. Patient was taking the medication one each in morning and evening. On 02-JUN-2021, patient was still walking slowly, tumbling and was not able to walk. On same day, patient also had a pain in left calf and fatigued. On 03-JUN-2021, patient went to the Emergency room(ER). Laboratory data included: Ultrasound scan (NR: not provided) which showed a blood clot in the right leg and left lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigued when walking, had not recovered from couldn't walk and left calf pain, and the outcome of walking slow / stumbling, muscle pain, blood clot in right calf and blood clot in left lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607546-covid-19 vaccine ad26.cov2.s -Blood clot in right calf, Blood clot in left lung, Couldn't walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210607546-covid-19 vaccine ad26.cov2.s -Fatigue when walking, muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.