Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Haematochezia, Inappropriate schedule of product administration
Clinical narrative: Blood in the poop; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of HAEMATOCHEZIA (Blood in the poop) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251202A, O9L20A or O2L20A, 037C21A, 084J21A and 006M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) tablet for Rheumatoid arthritis.    The patient's past medical history included Adrenal insufficiency (Adrenal insufficiency (Getting ready right now to start her on new medication)) and Potassium low (low potassium (Have to take medicine forever, for this)). Concurrent medical conditions included Diabetic (Diabetic), Glaucoma (Glaucoma), Cholesterol, Blood pressure and AFib. Concomitant products included APIXABAN (ELIQUIS) for AFib, DILTIAZEM (CARDIZEM [DILTIAZEM]), METOPROLOL and LOSARTAN for Blood pressure, ROSUVASTATIN CALCIUM for Cholesterol.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 milligram once a day. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in the poop) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in the poop) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, Glycosylated haemoglobin: 7.1. On 16-Aug-2022, Haematochezia:. On an unknown date, Haematochezia: Negative.    The patient was immunocompromised.  The last time the patient received a booster dose, her doctor told her not to take Xeljanz on the day of the vaccine or for 7 days afterward. She took the dose of Xeljanz a day before the day of this report and took the COVID vaccine (she forgot all about it and took the Xeljanz, was supposed to wait until 6 days afterward). The patient was advised to contact her rheumatologist.  The laboratory tests included a FIT test, and blood in the poop, the result came out as negative.  Treatment information was not provided. Company comment This is a spontaneous case reported by a patient concerning a 67-year-old female patient with relevant medical history of atrial fibrillation treated with Apixaban, who experienced the unexpected, serious (due to medically significant), event of Haematochezia. The patient received the first dose of mRNA-1273. Event onset date was unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Inappropriate schedule of product administration was considered an additional event. No further information regarding the course of the event, studies performed, treatment received was provided. The concomitant medication of Apixaban could be a contributory risk factor for haemorrhage and therefore Haematochezia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient concerning a 67-year-old female patient with relevant medical history of atrial fibrillation treated with Apixaban, who experienced the unexpected, serious (due to medically significant), event of Haematochezia. The patient received the first dose of mRNA-1273. Event onset date was unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Inappropriate schedule of product administration was considered an additional event. No further information regarding the course of the event, studies performed, treatment received was provided. The concomitant medication of Apixaban could be a contributory risk factor for haemorrhage and therefore Haematochezia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.