Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Foot fracture, Gait disturbance, Heart rate, Supraventricular tachycardia
Clinical narrative: Broke his left foot after booster; Supraventricular Tachycardia after booster; Increased Blood Pressure 141 mmHg after booster; Not able to do a lot of exercise and walking after Booster; Pain in the chest; 1 week after ablation, he developed a blood clot; Dizzy spells after booster; Fatigue after Booster; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (1 week after ablation, he developed a blood clot), FOOT FRACTURE (Broke his left foot after booster) and SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia after booster) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 044A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Skin cancer (Skin Cancer on the ear 4 years ago and removed by dermatologist. Since then, he visits dermatologist regularly.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced DIZZINESS (Dizzy spells after booster) and FATIGUE (Fatigue after Booster). In December 2021, the patient experienced THROMBOSIS (1 week after ablation, he developed a blood clot) (seriousness criterion medically significant), FOOT FRACTURE (Broke his left foot after booster) (seriousness criterion hospitalization), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia after booster) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Increased Blood Pressure 141 mmHg after booster), GAIT DISTURBANCE (Not able to do a lot of exercise and walking after Booster) and CHEST PAIN (Pain in the chest). The patient was hospitalized on sometime in December 2021 due to FOOT FRACTURE. The patient was treated with APIXABAN (ELIQUIS) for Anticoagulant therapy, at an unspecified dose and frequency. On 05-Jan-2022, THROMBOSIS (1 week after ablation, he developed a blood clot), FOOT FRACTURE (Broke his left foot after booster), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia after booster), BLOOD PRESSURE INCREASED (Increased Blood Pressure 141 mmHg after booster), CHEST PAIN (Pain in the chest), DIZZINESS (Dizzy spells after booster) and FATIGUE (Fatigue after Booster) had resolved. At the time of the report, GAIT DISTURBANCE (Not able to do a lot of exercise and walking after Booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood pressure measurement: 80/88 mmhg 80/88 mmHg and 141 mmhg 141 mmHg. In December 2021, Electrocardiogram: supraventricular tachycardia Supraventricular Tachycardia. In December 2021, Heart rate: 144 bpm 144 BPM.         Concomitant product use was not provided by the reporter.  In Dec-2021, the patient broke his left foot. He went to the hospital for the left foot. He also had pain in the chest. They transferred him to the emergency room where he underwent ablation. One week after ablation, he developed a blood clot. It was reported as after the ablation he was not able to do a lot of exercise and walking.  Treatment for the event included right leg cast, left foot cast, ablation and unspecified blood pressure medication.  Company comment: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected serious events of Thrombosis (AESI and medically significant), Supraventricular tachycardia (AESI and medically significant), and Foot fracture (hospitalization) which occurred unknown days after administration of booster dose of mRNA-1273 vaccine. chest pain. Patient broke his left foot and went to the hospital. He was transferred to emergency in view of chest pain, increased heart rate and blood pressure and was told that he needs an ablation. 1 week after ablation, he developed a blood clot. Electrocardiogram revealed Supraventricular Tachycardia. He was prescribed apixaban and blood Pressure Medication. The events resolved. The patient experienced events of Heart rate increased, Dizziness, Lower limb fracture after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-535893 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected serious events of Thrombosis (AESI and medically significant), Supraventricular tachycardia (AESI and medically significant), and Foot fracture (hospitalization) which occurred unknown days after administration of booster dose of mRNA-1273 vaccine. chest pain. Patient broke his left foot and went to the hospital. He was transferred to emergency in view of chest pain, increased heart rate and blood pressure and was told that he needs an ablation. 1 week after ablation, he developed a blood clot. Electrocardiogram revealed Supraventricular Tachycardia. He was prescribed apixaban and blood Pressure Medication. The events resolved. The patient experienced events of Heart rate increased, Dizziness, Lower limb fracture after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.