Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram QT prolonged, Heart rate, Hypotension, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Troponin increased; EKG looked like I had a heart attack; blood sugar increased; oxygen started to go down, but not below 88; heart hurt/It hurt if he took a deep breath; flu-like symptoms; ground glass infiltrates; bilateral pneumonia; Pleuritic chest pain; maculopapular rash; Inappropriate schedule of vaccine administered; myocarditis; heart hurt; shortness of breath; hypotensive; cough; cough; tachypnea; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (myocarditis), PNEUMONIA (bilateral pneumonia), DYSPNOEA (shortness of breath), HYPOTENSION (hypotensive), the first episode of COUGH (cough), CHEST PAIN (heart hurt), LUNG OPACITY (ground glass infiltrates), TACHYPNOEA (tachypnea), INFLUENZA LIKE ILLNESS (flu-like symptoms), OXYGEN SATURATION DECREASED (oxygen started to go down, but not below 88), CHEST DISCOMFORT (heart hurt/It hurt if he took a deep breath), MYOCARDIAL INFARCTION (EKG looked like I had a heart attack), TROPONIN INCREASED (Troponin increased), CHEST PAIN (Pleuritic chest pain), BLOOD GLUCOSE INCREASED (blood sugar increased), the second episode of COUGH (cough), RASH MACULO-PAPULAR (maculopapular rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     The patient's past medical history included Myocardial infarction in 2008, Pericarditis (He had an ablation in 2016 for atrial fibrillation, which resulted in hemorrhagic tamponade.), Atrial fibrillation (Atrial fibrillation in 2016 status post ablation) in 2016 and Cardiac ablation (hemorrhagic tamponade post ablation for atrial fibrillation). Previously administered products included for COVID-19 vaccination: pfizer (Dose-1, His hand broke down with almost herpes zoster; it really hurt, blistery, painful, and itchy.) on 01-Feb-2021, pfizer (Dose-2 His hand broke down with almost herpes zoster; it really hurt, blistery, painful and and itchy.) on 24-Feb-2021; for an unreported indication: METHOTREXATE. Past adverse reactions to the above products included Adverse event with pfizer and pfizer. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced the first episode of COUGH (cough) (seriousness criteria hospitalization and medically significant), TACHYPNOEA (tachypnea) (seriousness criteria hospitalization and medically significant) and INFLUENZA LIKE ILLNESS (flu-like symptoms) (seriousness criteria hospitalization and medically significant). On 10-Sep-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criteria hospitalization and medically significant), HYPOTENSION (hypotensive) (seriousness criteria hospitalization and medically significant) and the second episode of COUGH (cough) (seriousness criteria hospitalization and medically significant). On 11-Sep-2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (heart hurt) (seriousness criteria hospitalization and medically significant) and CHEST DISCOMFORT (heart hurt/It hurt if he took a deep breath) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PNEUMONIA (bilateral pneumonia) (seriousness criteria hospitalization and medically significant), LUNG OPACITY (ground glass infiltrates) (seriousness criteria hospitalization and medically significant), OXYGEN SATURATION DECREASED (oxygen started to go down, but not below 88) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (EKG looked like I had a heart attack) (seriousness criteria hospitalization and medically significant), TROPONIN INCREASED (Troponin increased) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criteria hospitalization and medically significant), BLOOD GLUCOSE INCREASED (blood sugar increased) (seriousness criteria hospitalization and medically significant), RASH MACULO-PAPULAR (maculopapular rash) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 11-Sep-2021 to 16-Sep-2021 due to CHEST PAINThe patient was hospitalized from 11-Sep-2021 to 16-Sep-2021 due to CHEST PAIN, COUGH, DYSPNOEA, HYPOTENSION, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, LUNG OPACITY, MYOCARDITIS, PNEUMONIA, RASH MACULO-PAPULAR and TACHYPNOEA. The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) for Heart attack, at a dose of 125 mg; DOXYCYCLINE at a dose of 100 mg twice a day; INSULIN for Diabetes, at an unspecified dose and frequency and HEPARIN at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis), PNEUMONIA (bilateral pneumonia), DYSPNOEA (shortness of breath), HYPOTENSION (hypotensive), CHEST PAIN (heart hurt), LUNG OPACITY (ground glass infiltrates), TACHYPNOEA (tachypnea), INFLUENZA LIKE ILLNESS (flu-like symptoms), OXYGEN SATURATION DECREASED (oxygen started to go down, but not below 88), CHEST DISCOMFORT (heart hurt/It hurt if he took a deep breath), MYOCARDIAL INFARCTION (EKG looked like I had a heart attack), TROPONIN INCREASED (Troponin increased), CHEST PAIN (Pleuritic chest pain), BLOOD GLUCOSE INCREASED (blood sugar increased), the last episode of COUGH (cough), RASH MACULO-PAPULAR (maculopapular rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: negative (Negative) IgG to nucleocapsid protein was negative.. On an unknown date, Blood test: high (High) His d-dimer was elevated, and 2700 (abnormal) spike protein was 2700.. On an unknown date, Electrocardiogram QT prolonged: high (High) QT interval increased.. On an unknown date, Heart rate: 135 (abnormal) heart rate went up to 135 with his pace maker.. On an unknown date, Oxygen saturation: 88 (abnormal) Oxygen started to go down, but not below 88.. On an unknown date, Troponin: 22 (abnormal) troponin was 22.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   He really had a hard time breathing, so he called the ambulance and brought Anakinra with him. He was in the hospital for 6 days, due to heart attack. He did a 6-minute walk test shows that his oxygen improved. and then he was fine. He talked to the head of infectious disease, who said he had COVID, but he tested negative for COVID twice. kidneys were messed up. After 5 days of Anakinra, his oxygen with walking briskly became normal and heart rate didn't go over 100. He was discharged from the hospital on 16Sep2021. His chest x-ray improved, and he has a high resolution CT scan scheduled next month. Treatment medication includeTopical steroid use d for maculopapular rash.  Company Comment : This case concerns a 71 year-old male patient with a history of 2 Tozinameran COVID-19 vaccine doses in 2021, rheumatoid arthritis on methotrexate, myocardial infarction in 2008, pericarditis, and atrial fibrillation in 2016 status post ablation and hemorrhagic tamponade who experienced the unexpected serious events of myocarditis, an AESI, pneumonia, hypotension, lung opacity, influenza like illness, maculopapular rash, increased blood glucose, and increased troponin. The events occurred approximately 3 to 5 days after the third dose of Moderna COVID-19 Vaccine. The medical history of rheumatoid arthritis on immunosuppressants, myocardial infarction, and pericarditis remain confounders for myocarditis and pneumonia. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 71 year-old male patient with a history of 2 Tozinameran COVID-19 vaccine doses in 2021, rheumatoid arthritis on methotrexate, myocardial infarction in 2008, pericarditis, and atrial fibrillation in 2016 status post ablation and hemorrhagic tamponade who experienced the unexpected serious events of myocarditis, an AESI, pneumonia, hypotension, lung opacity, influenza like illness, maculopapular rash, increased blood glucose, and increased troponin. The events occurred approximately 3 to 5 days after the third dose of Moderna COVID-19 Vaccine. The medical history of rheumatoid arthritis on immunosuppressants, myocardial infarction, and pericarditis remain confounders for myocarditis and pneumonia. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.