Sex: M
Vaccine: COVID19, FLUX, PPV
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; difficulty breathing; feeling like crap; ended up being really sick for a week or 10 days; had a high fever; was on death's door for about a week; This spontaneous case was reported by a nurse and describes the occurrence of NEAR DEATH EXPERIENCE (was on death's door for about a week) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU) for an unknown indication and PNEUMOCOCCAL VACCINE for an unknown indication.    Concurrent medical conditions included Cardiac disorder NOS (He had preexisting cardiac issues and was about 66 or 67 years old).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose and PNEUMOCOCCAL VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (was on death's door for about a week) (seriousness criterion medically significant), SARS-COV-2 TEST POSITIVE (tested positive for Covid), DYSPNOEA (difficulty breathing), FEELING ABNORMAL (feeling like crap), ILLNESS (ended up being really sick for a week or 10 days) and PYREXIA (had a high fever). At the time of the report, NEAR DEATH EXPERIENCE (was on death's door for about a week) and ILLNESS (ended up being really sick for a week or 10 days) had resolved and SARS-COV-2 TEST POSITIVE (tested positive for Covid), DYSPNOEA (difficulty breathing), FEELING ABNORMAL (feeling like crap) and PYREXIA (had a high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  Company comment: This case concerns an elderly male patient (no exact age was provided), with medical history of cardiac disorder NOS, who experienced serious unexpected event of near death experience and non serious unexpected AESI of SARS-COV-2 TEST POSITIVE  after dose of mRNA-1273. The events occurred after vaccination. No information regarding start date was provided. The re-challenge is unknown since no information regarding dose number was provided and for the event SARS-COV-2 TEST POSITIVE  the re-challenge is not applicable due to the nature of the event. Co-suspect products (flu vaccine and pneumonia vaccine) could be considered confounders for the event near death experience. Patient´s medical history of cardiac disorder could be considered a risk factor.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case concerns an elderly male patient (exact age was provided), with medical history of cardiac disorder NOS, who experienced serious unexpected event of near death experience and non-serious unexpected AESI of SARS-COV-2 TEST POSITIVE.. The events occurred after vaccination with COVID-19 Vaccine of unknown manufacturer, as per reporter statement. No information regarding onset date was provided. The rechallenge is unknown since no information regarding dose number was provided and for the event SARS-COV-2 TEST POSITIVE  the re-challenge is not applicable due to the nature of the event. Co-suspect products (flu vaccine and pneumonia vaccine) could be considered confounders for the event near death experience. Patient´s medical history of cardiac disorder could be considered a risk factor.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly male patient (exact age was provided), with medical history of cardiac disorder NOS, who experienced serious unexpected event of near death experience and non-serious unexpected AESI of SARS-COV-2 TEST POSITIVE.. The events occurred after vaccination with COVID-19 Vaccine of unknown manufacturer, as per reporter statement. No information regarding onset date was provided. The rechallenge is unknown since no information regarding dose number was provided and for the event SARS-COV-2 TEST POSITIVE  the re-challenge is not applicable due to the nature of the event. Co-suspect products (flu vaccine and pneumonia vaccine) could be considered confounders for the event near death experience. Patient´s medical history of cardiac disorder could be considered a risk factor.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.