Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, COVID-19, Hyponatraemia
Clinical narrative: Hyponatremia/sodium level of 100; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of HYPONATRAEMIA (Hyponatremia/sodium level of 100) 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 Hypertension, BPH and Drug allergy (Hydrochlorothiazide). Concomitant products included ALFUZOSIN, CLONIDINE, FELODIPINE, IRBESARTAN, ROSUVASTATIN, SPIRONOLACTONE and TRAZODONE for an unknown indication.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPONATRAEMIA (Hyponatremia/sodium level of 100) (seriousness criteria hospitalization and life threatening). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, HYPONATRAEMIA (Hyponatremia/sodium level of 100) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, Blood sodium: 100 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Pfizer co-suspect product for COVID-19 treatment from 18-May-2022 to 22-May-2022 orally.  Company comment: This spontaneous case concerns an 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected, serious (life-threatening, hospitalization) event of Hyponatremia (reported as Hyponatremia/sodium level of 100), and the unexpected, non-serious Adverse Event of Special Interest of COVID-19. The event Hyponatremia occurred 6 months, 11 days after the third dose of mRNA-1273 vaccine administration while the onset date of COVID-19 is unknown. Patient took Pfizer co-suspect product for COVID-19 treatment for 5 days.  The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. Intake of felodipine and irbesartan could be a confounder for the event Hyponatremia. Outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected, serious (life-threatening, hospitalization) event of Hyponatremia (reported as Hyponatremia/sodium level of 100), and the unexpected, non-serious Adverse Event of Special Interest of COVID-19. The event Hyponatremia occurred 6 months, 11 days after the third dose of mRNA-1273 vaccine administration while the onset date of COVID-19 is unknown. Patient took Pfizer co-suspect product for COVID-19 treatment for 5 days.  The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. Intake of felodipine and irbesartan could be a confounder for the event Hyponatremia. Outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.