Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Haemorrhoidal haemorrhage, Injection site erythema, Injection site papule, Injection site pruritus
Clinical narrative: Bloody diarrhea; rectal bleeding; Hemorrhoidal bleeding; Lower abdominal pain; Feeling anxious; Fear; injection site papule; constipation; Injection site itching; Defaecation urgency; Injection site redness; Injection site hives; Fever; Palpitation; Acne; Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and RECTAL HAEMORRHAGE (rectal bleeding) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohns disease aggravated and ADALIMUMAB (HUMIRA) solution for injection for Crohns disease aggravated.    The patient's past medical history included Soft stools and Constipation. Concurrent medical conditions included Pain abdominal (lower abdomen) and Diarrhea bloody (2 stools per day blood noted).   On 29-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. In February 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ACNE (Acne). In February 2021, the patient experienced PALPITATIONS (Palpitation) and PYREXIA (Fever). On 30-Apr-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE URTICARIA (Injection site hives). In 2021, the patient experienced DIARRHOEA (Diarrhea). On 29-Jun-2021, the patient experienced DEFAECATION URGENCY (Defaecation urgency). On an unknown date, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (rectal bleeding) (seriousness criterion medically significant), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), ABDOMINAL PAIN LOWER (Lower abdominal pain), ANXIETY (Feeling anxious), FEAR (Fear), INJECTION SITE PAPULE (injection site papule), CONSTIPATION (constipation) and INJECTION SITE PRURITUS (Injection site itching). In February 2021, PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea), RECTAL HAEMORRHAGE (rectal bleeding), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), DEFAECATION URGENCY (Defaecation urgency), PALPITATIONS (Palpitation), ABDOMINAL PAIN LOWER (Lower abdominal pain), ACNE (Acne), INJECTION SITE PAPULE (injection site papule), DIARRHOEA (Diarrhea), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE URTICARIA (Injection site hives) outcome was unknown and ANXIETY (Feeling anxious), FEAR (Fear) and CONSTIPATION (constipation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased. In 2021, Cardiac stress test: Negative. In 2021, Echocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-252737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Upon internal review on 08-Dec-2022 non-significant corrections performed to update "case received from field" to blank; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.