Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Haemoglobin, Influenza, Limb discomfort
Clinical narrative: Condition aggravated; Mitral valve incompetence; Condition aggravated; Steroid diabetes; pyrexia; Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at; Diarrhea; Weight fluctuation; Limb discomfort; Rash; Acute hypoxemic respiratory failure; pulmonary arterial hypertension; Influenza B; COVID-19; COVID-19 pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), INFLUENZA (Influenza B), the first episode of CONDITION AGGRAVATED (Condition aggravated), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the second episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) tablet for Systemic lupus erythematosus and an unknown indication and NIFEDIPINE for Hypertension.    The patient's past medical history included Calcium deficiency, Obstructive sleep apnea syndrome, Peripheral arterial disease, Shortness of breath and Continuous positive airway pressure. Family history included COVID-19 (Brother covid-19 positive). Concurrent medical conditions included Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation) since 01-Aug-2019, Systemic lupus erythematosus (on CPAP), Hypercalcemia, Hypertension, Systemic lupus erythematosis, Peripheral arterial occlusive disease and Dyspnoea. Concomitant products included AMBRISENTAN (LETAIRIS), SILDENAFIL CITRATE (REVATIO), CALCIUM CITRATE, ERGOCALCIFEROL (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), DIGOXIN (LANOXIN DIGOXIN), EPINEPHRINE (EPIPEN), ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID (FOLVITE [FOLIC ACID]), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), FUROSEMIDE (LASIX [FUROSEMIDE]), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and APIXABAN (ELIQUIS) for an unknown indication.   On 01-Aug-2019, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 milligram every eight hours. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 milligram every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose and TREPROSTINIL DIOLAMIN (ORENITRAM) (unknown route) dosage was changed to at an unspecified dose., METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (unknown route) 16 milligram once a day and NIFEDIPINE (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). On 06-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure) (seriousness criteria hospitalization and medically significant), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension) (seriousness criteria hospitalization and medically significant) and INFLUENZA (Influenza B) (seriousness criterion hospitalization). On an unknown date, the patient experienced the first episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence) (seriousness criteria hospitalization and medically significant), the second episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), STEROID DIABETES (Steroid diabetes) (seriousness criteria hospitalization and medically significant), PYREXIA (pyrexia) (seriousness criterion hospitalization), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), WEIGHT FLUCTUATION (Weight fluctuation) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). The patient was hospitalized from 23-Mar-2021 to 29-Mar-2021 due to COVID-19 PNEUMONIA, then on 06-Apr-2021 due to CONDITION AGGRAVATED, COVID-19, DIARRHOEA, INFLUENZA, LIMB DISCOMFORT, OEDEMA PERIPHERAL, PULMONARY ARTERIAL HYPERTENSION, PYREXIA, RASH, STEROID DIABETES and WEIGHT FLUCTUATION, and then on 16-Apr-2021 due to ACUTE RESPIRATORY FAILURE. On 29-Mar-2021, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown. On 26-Apr-2021, INFLUENZA (Influenza B) outcome was unknown. At the time of the report, ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the last episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: up by 4 lbs since discharge from hospital (Inconclusive) up by 4 lbs since discharge from hospital. On 21-Apr-2021, Catheterisation cardiac: abnormal (abnormal) Revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52. On 24-Apr-2021, Blood creatinine: 1.68 (Inconclusive) 1.68. On 24-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 24-Apr-2021, Blood potassium: 4.1 (Inconclusive) 4.1. On 24-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 24-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 24-Apr-2021, Haemoglobin: 8.4 (Inconclusive) 8.4. On 24-Apr-2021, Platelet count: 146 (Inconclusive) 146. On 24-Apr-2021, Red blood cell count: 3.31 (Inconclusive) 3.31. On 24-Apr-2021, White blood cell count: 4.79 (Inconclusive) 4.79. On 25-Apr-2021, Blood creatinine: 1.59 (Inconclusive) 1.59. On 25-Apr-2021, Blood glucose: 117 (Inconclusive) 117. On 25-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 25-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 25-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 25-Apr-2021, Haemoglobin: 8.2 (Inconclusive) 8.2. On 25-Apr-2021, Platelet count: 159 (Inconclusive) 159. On 25-Apr-2021, Red blood cell count: 3.24 (Inconclusive) 3.24. On 25-Apr-2021, White blood cell count: 5.51 (Inconclusive) 5.51. On 26-Apr-2021, Blood creatinine: 1.54 (Inconclusive) 1.54. On 26-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 26-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 26-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 26-Apr-2021, Blood urea: 37 (Inconclusive) 37. On 26-Apr-2021, Haemoglobin: 8.3 (Inconclusive) 8.3. On 26-Apr-2021, Platelet count: 159 (Inconclusive) 159. On 26-Apr-2021, Red blood cell count: 3.30 (Inconclusive) 3.30. On 26-Apr-2021, White blood cell count: 5.41 (Inconclusive) 5.41. In 2021, Body temperature: 101.1 (High) 101.1 F. In 2021, Weight: stable at 155 lbs slowly coming down (Inconclusive) stable at 155 lbs  slowly coming down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.