Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cardiac disorder, Hypokinesia, Lethargy, Pneumonia
Clinical narrative: He was also having some form of pneumonia/Not feeling well/fever; enzymes were leaking out of his heart; he threw up at midnight; lethargic; could not control his urine; could not move/unable to get up; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (He was also having some form of pneumonia/Not feeling well/fever) and CARDIAC DISORDER (enzymes were leaking out of his heart) in an 82-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3033089) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: RSV. Past adverse reactions to the above products included No adverse event with RSV. Concurrent medical conditions included Blood pressure high and Allergy to vaccine (Tetanus vaccine).    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Dec-2023, the patient experienced LETHARGY (lethargic), URINARY INCONTINENCE (could not control his urine) and HYPOKINESIA (could not move/unable to get up). On 15-Dec-2023, the patient experienced PNEUMONIA (He was also having some form of pneumonia/Not feeling well/fever) (seriousness criteria hospitalization and medically significant) and CARDIAC DISORDER (enzymes were leaking out of his heart) (seriousness criterion hospitalization). 15-Dec-2023, the patient experienced VOMITING (he threw up at midnight). The patient was hospitalized for 4 days due to CARDIAC DISORDER and PNEUMONIA. At the time of the report, PNEUMONIA (He was also having some form of pneumonia/Not feeling well/fever), LETHARGY (lethargic) and HYPOKINESIA (could not move/unable to get up) had not resolved and CARDIAC DISORDER (enzymes were leaking out of his heart), URINARY INCONTINENCE (could not control his urine) and VOMITING (he threw up at midnight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2023, Body temperature: 106 F and 104.8.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient was on medications. He took medication for high blood pressure. Patient had a very bad reaction to the Moderna vaccine. Patient felt like he had been drugged. Patient ended up it he hospital the next morning on 15-DEC-2023. Patient had no signs of getting sick whatsoever. He was in the hospital for 4 days. Caller reported having to pull him to help him use the bathroom because he was unable to get up. Patient went to see the cardiologist because they said the shot had something to do with his heart. No treatment information was reported.  Company comment: This spontaneous case concerns an 82-year-old male patient, with medical history of high blood pressure, who experienced the unexpected and serious (hospitalization and medically significant) event of PNEUMONIA and the unexpected and serious (hospitalization) event of CARDIAC DISORDER, among other non-serious events, on the following day of an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. No details of previous doses were provided. On the same day of vaccination, he was lethargic with no control of his urine, and with fever the next morning. He was hospitalized for 4 days. Patient´s age, and his medical history could be a risk factor for his cardiac disorder. Very limited information regarding this event has been provided, further information has been requested. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.