Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Haemorrhoidal haemorrhage, Injection site erythema, Injection site papule, Injection site pruritus
Clinical narrative: Feeling anxious; Defaecation urgency; Injection site itching; Injection site hives; Injection site redness; Fever; Palpitation; ACNE; Hemorrhoidal bleeding; Bloody diarrhoea; Rectal bleeding; Fear; Constipation; Lower abdominal pain; Diarrhoea; Injection site papule; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) 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 Abdominal pain lower, Diarrhea (Diarrhoea/Loose stools 2 Per day/Blood noted), Constipation and Loose stools.   On 29-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram once a day. On 12-Feb-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram once a day. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a day. 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 PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE ERYTHEMA (Injection site redness). In 2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), FEAR (Fear), CONSTIPATION (Constipation), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), ABDOMINAL PAIN LOWER (Lower abdominal pain), DIARRHOEA (Diarrhoea) and INJECTION SITE PAPULE (Injection site papule). On 29-Jun-2021, the patient experienced DEFAECATION URGENCY (Defaecation urgency). On an unknown date, the patient experienced ANXIETY (Feeling anxious). In February 2021, PYREXIA (Fever) had resolved. In 2021, INJECTION SITE PAPULE (Injection site papule) had resolved, INJECTION SITE PRURITUS (Injection site itching) had not resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), RECTAL HAEMORRHAGE (Rectal bleeding), ACNE (ACNE), DEFAECATION URGENCY (Defaecation urgency), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), PALPITATIONS (Palpitation) and ABDOMINAL PAIN LOWER (Lower abdominal pain) outcome was unknown and FEAR (Fear), CONSTIPATION (Constipation), ANXIETY (Feeling anxious), DIARRHOEA (Diarrhoea), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased mmHg (High) Increased Blood Pressure was noted.. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Echocardiogram: negative (Negative) Negative.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No Treatment medication reported  Patient was involved in Facilitated Collect Clinical Study. Manufacture Control No for Co-suspect drug.: 21K-163-3803366-00  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. Unlikely, that the events are related to the vaccine. Patient has Chiron's disease, Further information is expected.   This case was linked to MOD-2021-252736 (Patient Link).; Reporter's Comments: This case was received from AbbVie.; 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. Unlikely, that the events are related to the vaccine. Patient has Chiron's disease, Further information is expected.