Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Asthenia, Atrioventricular block complete, Blood test, Cardiac monitoring
Clinical narrative: 100Degree Heart block; blood clot on the subclavian/dozens of blood clots; severe headache; vomiting; severe inflammatory reaction; "crazy, insane, brain fog"/It was super painful like waves going into my body/symptoms were like coming waves; was really confused; was very bad; Left arm was swollen; joint hurting; left arm hurt/muscle aches/left arm felt like a huge pain/It was super painful like waves going into my body; This spontaneous case was reported by a consumer and describes the occurrence of ATRIOVENTRICULAR BLOCK (100Degree Heart block), SUBCLAVIAN VEIN THROMBOSIS (blood clot on the subclavian/dozens of blood clots), HEADACHE (severe headache), VOMITING (vomiting) and INFLAMMATION (severe inflammatory reaction) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) (Pacemaker was placed by the end of April 2021) in April 2021.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ATRIOVENTRICULAR BLOCK (100Degree Heart block) (seriousness criterion hospitalization), SUBCLAVIAN VEIN THROMBOSIS (blood clot on the subclavian/dozens of blood clots) (seriousness criteria hospitalization and medically significant), HEADACHE (severe headache) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), INFLAMMATION (severe inflammatory reaction) (seriousness criterion hospitalization), CONFUSIONAL STATE (was really confused), FEELING ABNORMAL (was very bad), PERIPHERAL SWELLING (Left arm was swollen), ARTHRALGIA (joint hurting) and MYALGIA (left arm hurt/muscle aches/left arm felt like a huge pain/It was super painful like waves going into my body). On an unknown date, the patient experienced FEELING ABNORMAL ("crazy, insane, brain fog"/It was super painful like waves going into my body/symptoms were like coming waves). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to ATRIOVENTRICULAR BLOCK, HEADACHE, INFLAMMATION, SUBCLAVIAN VEIN THROMBOSIS and VOMITING. The patient was treated with PREDNISONE in April 2021 for Inflammatory reaction, at an unspecified dose and frequency. At the time of the report, ATRIOVENTRICULAR BLOCK (100Degree Heart block), SUBCLAVIAN VEIN THROMBOSIS (blood clot on the subclavian/dozens of blood clots), HEADACHE (severe headache), VOMITING (vomiting), INFLAMMATION (severe inflammatory reaction), FEELING ABNORMAL ("crazy, insane, brain fog"/It was super painful like waves going into my body/symptoms were like coming waves), CONFUSIONAL STATE (was really confused), FEELING ABNORMAL (was very bad), PERIPHERAL SWELLING (Left arm was swollen), ARTHRALGIA (joint hurting) and MYALGIA (left arm hurt/muscle aches/left arm felt like a huge pain/It was super painful like waves going into my body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) arm was swollen.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. Patient states was diagnosed with severe inflammatory reaction after second shot, patient mention that 20 min after getting the second shot experienced "crazy, insane, brain fog" was really confused. the same night around 8pm 9pm patient states came down with a severe headache that only experienced when patient had tick fever in his 20, was very bad and also had vomiting, patient states was really rough. at that time patient mention thinking will be only side effects on Monday patient states realizing something was wrong, due symptoms were like coming waves  and that after a blunt movement headache increased started vomiting also having joint hurting, muscle aches, patient though was having a stroke so call 911 and went to ER on 16Apr2021 hospitalized in the ICU until 19Apr2021 patient mention when arriving ER was 100Degree Heart block, states " It was super painful like waves going into my body" Neurologist diagnosed with Severe Inflammatory reaction and prescribed Prednisone. Patient states " i left the hospital with a pacemaker"  patient mention pacemaker was  placed by the end of April 2021. Patient mention after that couldn't get back to work, joint hurts, mention that after a regular movement with his left arm felt like a huge pain, hurt and saw on the top of his bicep blood vessels broken, went to the hospital get X-rays arm was swollen, patient got an Ultrasound due Neurologist suspicious about blood clots, found and intervention on time a blood clot on the subclavian, and dozens of blood clots.Patient mention that next January 2022 had a date to preform and ultrasound to see the evolution of medication  Company Comment  This case concerns a 61-year-old male patient with no relevant medical history, who experienced the serious unexpected events of Atrioventricular block(AESI), Subclavian vein thrombosis, Headache, Vomiting and Inflammation. The events occurred the same month after the second dose of mRNA-1273 vaccine. (Start date of events not provided). The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old male patient with no relevant medical history, who experienced the serious unexpected events of Atrioventricular block(AESI), Subclavian vein thrombosis, Headache, Vomiting and Inflammation. The events occurred the same month after the second dose of mRNA-1273 vaccine. (Start date of events not provided). The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.