Received May 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Fluid overload; Incoherent; Orenitram medication failure; Wound on left big toe from an injury; Headache; Nausea; Flushing; Cardiac arrest; Lung inflammation from COVID-19 Moderna vaccine; Immunisation reaction; Diabetes; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest), PNEUMONITIS (Lung inflammation from COVID-19 Moderna vaccine), IMMUNISATION REACTION (Immunisation reaction), HYPERVOLAEMIA (Fluid overload), INCOHERENT (Incoherent), THERAPY NON-RESPONDER (Orenitram medication failure) and DIABETES MELLITUS (Diabetes) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Treprostinil diolamine (Orenitram) for Primary pulmonary hypertension, Treprostinil for Primary pulmonary hypertension and Epoprostenol sodium (Flolan) for Primary pulmonary hypertension. The patient's past medical history included Central venous catheterisation (Peripherally inserted central catheterisation switched to tunneled catheter) in 2021. Concurrent medical conditions included Primary pulmonary hypertension (Primary Pulmonary arterial hypertension). Concomitant products included Riociguat (Adempas) and Ambrisentan (Letairis) for an unknown indication. On 08-Jul-2014, the patient Treprostinil diolamine (Orenitram) (Oral use) dosage was changed to 5 milligram. In 2021, the patient started Epoprostenol sodium (Flolan) (Intravenous use) at an unspecified dose. In October 2021, the patient started Treprostinil (Intravenous use) 5 mg/ml at continuous frequency. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and Treprostinil diolamine (Orenitram) (Oral use) at an unspecified dose. On an unknown date, Treprostinil diolamine (Orenitram) (Oral use) dosage was changed to at an unspecified dose and Treprostinil diolamine (Orenitram) (Oral use) dosage was changed to 5 milligram three times a day. In 2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria medically significant, life threatening and intervention required), PNEUMONITIS (Lung inflammation from COVID-19 Moderna vaccine) (seriousness criterion medically significant), IMMUNISATION REACTION (Immunisation reaction) (seriousness criterion medically significant), HYPERVOLAEMIA (Fluid overload) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), THERAPY NON-RESPONDER (Orenitram medication failure) (seriousness criterion hospitalization) and DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). In October 2021, the patient experienced FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced LIMB INJURY (Wound on left big toe from an injury). The patient was hospitalized from sometime in 2021 to 08-Oct-2021 due to HYPERVOLAEMIA, INCOHERENT and THERAPY NON-RESPONDER. In 2021, CARDIAC ARREST (Cardiac arrest) had resolved. In October 2021, FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, PNEUMONITIS (Lung inflammation from COVID-19 Moderna vaccine), IMMUNISATION REACTION (Immunisation reaction), HYPERVOLAEMIA (Fluid overload), INCOHERENT (Incoherent), THERAPY NON-RESPONDER (Orenitram medication failure), DIABETES MELLITUS (Diabetes) and LIMB INJURY (Wound on left big toe from an injury) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: 114.3 kilogram Weight (252 lb). On 11-Oct-2021, Weight: 109.7 kilogram Weight (242 lb). In October 2021, Weight: 115.7 kilogram Weight (255.2 lb). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that the patient was hospitalized for Orenitram medication failure, fluid overload and was incoherent the majority of the time during the admission. She was also diagnosed with diabetes. As of 04-Oct-2021, she was in hospital and had been transitioned from Orenitram to intravenous epoprostenol and Orenitram was discontinued. The plan was to flip her to intravenous Remodulin (treprostinil sodium) upon discharge, but she went on intravenous generic treprostinil instead of brand Remodulin. It was also reported that the nurse switched her treprostinil medication from her peripherally inserted central catheter (PICC) line to her new tunneled catheter. The nurse measured the fill volume and then very slowly did an intravenous push of 75 percent of fill volume till the patient was symptomatic with headache, nausea and flushing. Her blood pressure was stable, and the headache, nausea and flushing were resolved within an hour. The prescribing physician ordered prednisone daily. She also had wound on left big toe from an injury (limb injury) and was taking her second round out of 3 rounds of antibiotics. It was reported that what took the patient out was the COVID shot and then she went into cardiac arrest in 2021. She then started Flolan (epoprostenol sodium) and was switched to intravenous generic treprostinil pump in the intensive care unit (ICU). However, it was reported the patient was currently (at the time of reporting) taking three medications already from the specialty pharmacy, so she was familiar with how that worked. Moreover, she was on Orenitram study as patient and did the whole trial so she was already aware of that drug, so she did not need a nurse visit. Action taken with Orenitram for the events of fluid overload, incoherent, therapy non-responder, diabetes mellitus was withdrawn. Action taken with Orenitram for the events of pneumonitis and limb injury was not reported and for the events of headache, nausea and flushing was not applicable. Action taken with intravenous generic treprostinil dose for the events of fluid overload, incoherent, diabetes mellitus, headache, nausea, flushing, pneumonitis and limb injury was not reported and for the event of therapy non-responder was not applicable. Action taken with Flolan for the events of fluid overload, incoherent, diabetes mellitus, therapy non-responder, headache, nausea, flushing, pneumonitis, and limb injury was not reported. The reporter's causality for the events of pneumonitis and cardiac arrest with COVID-19 Moderna vaccine was considered to be possibly related. The reporter did not provide a causality assessment for the events of fluid overload, incoherent, diabetes mellitus, headache, nausea, flushing, pneumonitis, limb injury and cardiac arrest with Orenitram, generic Treprostinil and Flolan. The reporter assessed the casual relationship between Orenitram and the event of therapy non-responder as possible. The reporter did not provide causality assessment for the event of therapy non-responder with generic Treprostinil and Flolan.; Reporter's Comments: The events Therapy non-responder and limb injury are assessed as not related due to related to suspect drug Treprostinil and toe wound, respectively. The benefit-risk relationship of product is not affected by this report.
Primary pulmonary hypertension (Primary Pulmonary arterial hypertension)
Medical History/Concurrent Conditions: Central venous catheterisation (Peripherally inserted central catheterisation switched to tunneled catheter)
Adempas; Letairis; Orenitram; Treprostinil; Flolan
Test Date: 2021; Test Name: Weight; Test Result: 114.3 kg; Test Date: 20211011; Test Name: Weight; Test Result: 109.7 kg; Test Date: 202110; Test Name: Weight; Test Result: 115.7 kg