Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Haematochezia
Clinical narrative: Atrial fibrillation; Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Chronic kidney disease (Improved). Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE), ROSUVASTATIN, AMLODIPINE from 06-Mar-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) (seriousness criterion medically significant). On 21-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Anticoagulant therapy, at a dose of UNK, bid. On 17-Apr-2021, HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included multivitamin.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-216141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received contains no new information. On 01-Jul-2021: Follow up received on 01-Jul-2021, no new information was recorded On 02-Jul-2021: Reporter details, patient details, medical history, concomitant drugs were added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.