Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Hallucination, Nausea, Oesophagogastroduodenoscopy, Stoma site haemorrhage
Clinical narrative: HIGH D-DIMER; Clot blood; LOW MAGNESIUM; BLEEDING AGAIN FROM STOMA SITE; BLEEDING FROM STOMA SITE; Lost weight; BOTH PEG AND J TUBES THE CAPS WERE LEAKING; PUMP TUBING AND STOMACH TUBING MALFUNCTIONED AND CASSETTE TUBE AND STOMACH TUBE BOTH LEAK; Nausea; Vomiting; HALLUCINATIONS with DUOPA (LEVODOPA/CARBIDOPA); This spontaneous case was reported by a consumer and describes the occurrence of FIBRIN D DIMER INCREASED (HIGH D-DIMER), THROMBOSIS (Clot blood), BLOOD MAGNESIUM DECREASED (LOW MAGNESIUM), STOMA SITE HAEMORRHAGE (BLEEDING AGAIN FROM STOMA SITE), HALLUCINATION (HALLUCINATIONS with DUOPA (LEVODOPA/CARBIDOPA)) and STOMA SITE HAEMORRHAGE (BLEEDING FROM STOMA SITE) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0710A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) gastroenteral suspension for Parkinson's disease, CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) tablet for Parkinson's disease and PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Parkinson's disease.    Concurrent medical conditions included Diabetic, Hypertension, Drug allergy (Sinemet allergy manifested by nausea and vomiting.), Drug allergy (Mirapex allergy manifested by hallucinations), Drug allergy (Rytary allergy manifested by nausea/vomiting), Smoker (Tobacco use/smokes a pipe), Abstains from alcohol and Parkinson's disease. Concomitant products included INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) for Diabetes, LISINOPRIL for Hypertension, QUETIAPINE for Parkinson's disease.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) (unknown route) at an unspecified dose. In June 2021, the patient started CARBIDOPA, LEVODOPA (DUOPA) (unknown route) Percutaneous J-tube. On 27-Nov-2021, CARBIDOPA, LEVODOPA (DUOPA) (unknown route) dosage was changed to Percutaneous J-tube. On an unknown date, the patient started CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) (unknown route) at an unspecified dose. In June 2021, the patient experienced FIBRIN D DIMER INCREASED (HIGH D-DIMER) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criteria hospitalization and medically significant) and BLOOD MAGNESIUM DECREASED (LOW MAGNESIUM) (seriousness criterion hospitalization). In 2021, the patient experienced HALLUCINATION (HALLUCINATIONS with DUOPA (LEVODOPA/CARBIDOPA)) (seriousness criterion medically significant). In June 2021, the patient experienced FIBRIN D DIMER INCREASED (HIGH D-DIMER) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criteria hospitalization and medically significant) and BLOOD MAGNESIUM DECREASED (LOW MAGNESIUM) (seriousness criterion hospitalization). In November 2021, the patient experienced WEIGHT DECREASED (Lost weight), DEVICE LEAKAGE (BOTH PEG AND J TUBES THE CAPS WERE LEAKING), DEVICE ISSUE (PUMP TUBING AND STOMACH TUBING MALFUNCTIONED AND CASSETTE TUBE AND STOMACH TUBE BOTH LEAK), NAUSEA (Nausea) and VOMITING (Vomiting). On 17-Nov-2021, the patient experienced STOMA SITE HAEMORRHAGE (BLEEDING FROM STOMA SITE) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced STOMA SITE HAEMORRHAGE (BLEEDING AGAIN FROM STOMA SITE) (seriousness criterion medically significant). The patient was hospitalized from sometime in June 2021 to sometime in June 2021 due to BLOOD MAGNESIUM DECREASED, FIBRIN D DIMER INCREASED and THROMBOSIS. The patient was treated with IRON at an unspecified dose and frequency. In 2021, THROMBOSIS (Clot blood) and BLOOD MAGNESIUM DECREASED (LOW MAGNESIUM) had resolved. In November 2021, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. On 19-Nov-2021, STOMA SITE HAEMORRHAGE (BLEEDING FROM STOMA SITE) had resolved. At the time of the report, FIBRIN D DIMER INCREASED (HIGH D-DIMER), STOMA SITE HAEMORRHAGE (BLEEDING AGAIN FROM STOMA SITE), HALLUCINATION (HALLUCINATIONS with DUOPA (LEVODOPA/CARBIDOPA)), WEIGHT DECREASED (Lost weight), DEVICE LEAKAGE (BOTH PEG AND J TUBES THE CAPS WERE LEAKING) and DEVICE ISSUE (PUMP TUBING AND STOMACH TUBING MALFUNCTIONED AND CASSETTE TUBE AND STOMACH TUBE BOTH LEAK) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Blood magnesium: Low. In June 2021, Fibrin D dimer: High. In 2021, Weight: 154 Pounds. In November 2021, Weight: 139 Pounds. On 19-Nov-2021, Oesophagogastroduodenoscopy: bleeding at stoma.         Company comment: This is a spontaneous case concerning a 66-year-old male patient with diabetes, hypertension and  Parkinson´s disease on treatment with Mirapex, Duopa and Sinemet (carbidopa, levodopa), who experienced the serious unexpected events blood magnesium decreased, fibrin d-dimer increased, trombosis and stoma site haemorrhage. Approximately 2-3 months after the second dose of mRNA-1273, patient was hospitalized for two to tree days due to low magnesium and high d-dimer, "sugesting blood clots". Clinical course, diagnostic tests and treatment details during hospitalization were not provided. Five months later, procedure was performed to replace Peg-j tube due to occlusion, and patient´s experienced bleeding from the stoma site from replacement procedure. After cauterization of the skin of the stoma, bleeding started again and a Esophagogastroduodenoscopy was performed and the gastroenterologist cauterized the bleeding again.  Mirapex, Duopa and Sinemet  was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. The patient was not in a clinical trial for COVID vaccine.  The patient was hospitalized for two to three days in Jun-2021 due to low magnesium and high d-dimer, suggesting blood clots. Treatment and other tests during hospitalization were not readily known by patient's daughter. The patient's daughter attributed the blood clots to the use of the COVID vaccine. In 2021, he experienced hallucinations due to Mirapex. The Peg-j tube was replaced due to occlusion. He could not flush tube and went to local emergency room. They could not unclog tube. He took oral medications over the weekend. Tube occlusion to doctor on 15-Nov-2021. The patient had to have surgery to replace the tube on 16-Nov-2021, prior to his tube being replaced patients perviou; Sender's Comments: Company comment: This is a spontaneous case concerning a 66-year-old male patient with diabetes, hypertension and  Parkinson´s disease on treatment with Mirapex, Duopa and Sinemet (carbidopa, levodopa), who experienced the serious unexpected events blood magnesium decreased, fibrin d-dimer increased, trombosis and stoma site haemorrhage. Approximately 2-3 months after the second dose of mRNA-1273, patient was hospitalized for two to tree days due to low magnesium and high d-dimer, "sugesting blood clots". Clinical course, diagnostic tests and treatment details during hospitalization were not provided. Five months later, procedure was performed to replace Peg-j tube due to occlusion, and patient´s experienced bleeding from the stoma site from replacement procedure. After cauterization of the skin of the stoma, bleeding started again and a Esophagogastroduodenoscopy was performed and the gastroenterologist cauterized the bleeding again.  Mirapex, Duopa and Sinemet  was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.