Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: covid-19 infection; hypoxia; Bilateral lung infiltrate; Cough; weakness; Chills; Covid-19 infection 19 days after COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (covid-19 infection), HYPOXIA (hypoxia), LUNG INFILTRATION (Bilateral lung infiltrate), COUGH (Cough), ASTHENIA (weakness) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       Concurrent medical conditions included Heart transplant (0.58 years from treatment for COVID-19) and Cardiomyopathy (Cause for heart transplant was Nonischemic cardiomyopathy). Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 infection) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criterion hospitalization prolonged), LUNG INFILTRATION (Bilateral lung infiltrate) (seriousness criterion hospitalization prolonged), COUGH (Cough) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged) and VACCINE BREAKTHROUGH INFECTION (Covid-19 infection 19 days after COVID-19 vaccine). The patient was hospitalized for 5 days due to ASTHENIA, CHILLS, COUGH, COVID-19, HYPOXIA and LUNG INFILTRATION. At the time of the report, COVID-19 (covid-19 infection), HYPOXIA (hypoxia), LUNG INFILTRATION (Bilateral lung infiltrate), COUGH (Cough), ASTHENIA (weakness) and CHILLS (Chills) outcome was unknown and VACCINE BREAKTHROUGH INFECTION (Covid-19 infection 19 days after COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: >0.3 mg/dl milligram per decilitre (abnormal) >0.3 mg/dl. On an unknown date, Lymphopenia: <900/mcl (abnormal) <900/mcL. On an unknown date, Oxygen saturation: <92% (abnormal) Hypoxia. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients were comparable to those of solid organ transplant patients (SOTs) who had COVID-19 infection and have not been vaccinated. Antinucleocapside antibody at COVID-19 diagnosis was also negative. Treatment for COVID-19 was with Remdesivir and Convalescent Plasma. Patient was discharged on 2 liters of oxygen.  Very limited information regarding this event has been provided at this time.  The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection.  Very limited information regarding this event has been provided at this time.  The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection.   This case was linked to MOD-2021-094284, MOD-2021-094289, MOD-2021-094295 (E2B Linked Report). This case was linked to MOD-2021-094316 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection. MOD-2021-094284: MOD-2021-094289: MOD-2021-094295: