Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Feels like he is going to pass out.; All his extremities are ice cold; Blood pressure is dangerously low; diarrhea; Throwing up; Fever; Pneumonia; His heart was in A-Fib; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and ATRIAL FIBRILLATION (His heart was in A-Fib) in a 63-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 Hypertension and Cancer.    On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ATRIAL FIBRILLATION (His heart was in A-Fib) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), PRESYNCOPE (Feels like he is going to pass out.), PERIPHERAL COLDNESS (All his extremities are ice cold), HYPOTENSION (Blood pressure is dangerously low), DIARRHOEA (diarrhea), VOMITING (Throwing up) and PYREXIA (Fever). At the time of the report, PNEUMONIA (Pneumonia) had resolved and ATRIAL FIBRILLATION (His heart was in A-Fib), PRESYNCOPE (Feels like he is going to pass out.), PERIPHERAL COLDNESS (All his extremities are ice cold), HYPOTENSION (Blood pressure is dangerously low), DIARRHOEA (diarrhea), VOMITING (Throwing up) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.         No relevant concomitant medications were reported  No treatment information was provided.  Company Comment: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and cancer, who experienced the unexpected events of pneumonia and atrial fibrillation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The events were considered related to the product per the reporter's assessment. The medical history of hypertension and cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and cancer, who experienced the unexpected events of pneumonia and atrial fibrillation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The events were considered related to the product per the reporter's assessment. The medical history of hypertension and cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.