Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Headache, Large intestinal stenosis, Nasopharyngeal swab, Nasopharyngitis
Clinical narrative: Stricture of colon; anemic; Nervousness; Common cold; headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL STENOSIS (Stricture of colon) in a 60-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 product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Ex-tobacco user (A pack of ciggerete a day) from 1977 to 2009, Bowel obstruction in 2019, Deep vein thrombosis leg in 2015, Emphysema from November 2020 to December 2020, Common cold from November 2020 to December 2020, COVID-19 from November 2020 to December 2020, Proctectomy since 2003, Stricture intestinal since 2010 and Ileostomy. Concurrent medical conditions included Alcohol use, Neuropathy, Dust allergy (MANIFESTED BY SINUS REACTION), Crohn's disease, Acid reflux (esophageal) and Digestion impaired. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), FOLIC ACID and MERCAPTOPURINE for Crohn's disease, PANCREATIN (CREON) for Digestion impaired, PROPRANOLOL for Pulse rate, VITAMIN D3 and POTASSIUM for Supplementation therapy.   In 2013, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), NASOPHARYNGITIS (Common cold) and HEADACHE (headache). On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Stricture of colon) (seriousness criteria hospitalization and medically significant), ANAEMIA (anemic) and NERVOUSNESS (Nervousness). The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (headache) had resolved. At the time of the report, LARGE INTESTINAL STENOSIS (Stricture of colon), ANAEMIA (anemic), NERVOUSNESS (Nervousness) and NASOPHARYNGITIS (Common cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, Nasopharyngeal swab: Covid 19 Positive.         No relevant concomitant medications were reported.   The reporter's causality for the events of bowel obstruction, recurring colon stricture, deep vein thrombosis on right leg, emphysema, anemic, recurring nervousness, difficulty in swallowing, colds,pain in the arm,recurred pain in the arm and covid-19 with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.   Abbvie's opinion is that there is no reasonable possibility that the events of bowel obstruction, recurring colon stricture, deep vein thrombosis on right leg, emphysema, anemic, recurring nervousness, difficulty in swallowing, fell, colds, pain in the arm, recurred pain in the arm, pain on the left hip, covid-19 and are related to humira 40mg/0.4ml(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the event of colds onset 17 feb 2021 is related to humira 40mg/0.4ml(adalimumab). It was unknown if she was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.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. C  Company comment: This spontaneous case concerns a 60 year old female patient with relevant medical history of intestinal stricture and Crohn s disease, who experienced the unexpected serious (hospitalization) event Large intestinal stenosis, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine about 1 month ago with no reported adverse events. She reported more stricture of her bowel and underwent surgery about 4 months after the second dose. Medical history of intestinal stricture could be confounding for the event. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-620570 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 year old female patient with relevant medical history of intestinal stricture and Crohn s disease, who experienced the unexpected serious (hospitalization) event Large intestinal stenosis, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine about 1 month ago with no reported adverse events. She reported more stricture of her bowel and underwent surgery about 4 months after the second dose. Medical history of intestinal stricture could be confounding for the event. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.