Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Colonoscopy, Large intestine polyp, SARS-CoV-2 test
Clinical narrative: three polyps were found and removed; Asthmatic attack; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINE POLYP (three polyps were found and removed) in a 75-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 Ankylosing spondylitis.    The patient had been having one or more routine chest x-ray since the she started on HUMIRA due to history of tuberculosis. The patient was non-tobacco user.  The patient's past medical history included Tuberculosis (9 months antibiotic treatment and was cleared before she started on HUMIRA. patient had been having one or more routine chest Xray since she started on HUMIRA). Family history included Gastrointestinal disorder NOS (The patient had been having colonoscopy every three years because she had family predisposition for colon problems.) since an unknown date. Concurrent medical conditions included Asthma, Barrett's esophagus since 2003, Drug allergy (ACE INHIBITORS ALLERGY MANIFESTED BY ASTHMA ATTACK), Latex allergy (LATEX ALLERGY MANIFESTED BY BLEEDING AND DELAYAED ASTHMA), Nausea, Blood pressure high, Alcohol use (Rarely drink) and Ankylosing spondylitis since 2016. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, PIOGLITAZONE HYDROCHLORIDE (DIAVANCE [PIOGLITAZONE HYDROCHLORIDE]) for Blood pressure high, ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, MAGNESIUM, VITAMIN B COMPLEX and CALCIUM, COLECALCIFEROL (CALCIUM PLUS VITAMIN D) for Supplementation therapy.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ASTHMA (Asthmatic attack). On 07-Oct-2021, the patient experienced LARGE INTESTINE POLYP (three polyps were found and removed) (seriousness criterion medically significant). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at an unspecified dose and frequency and Surgery (colonoscopy) for Large intestine polyp. In 2021, LARGE INTESTINE POLYP (three polyps were found and removed) and ASTHMA (Asthmatic attack) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Chest X-ray: No significant result. In 2021, SARS-CoV-2 test: (Negative) Negative. On 07-Oct-2021, Colonoscopy: three polyps were found and was removed during the colonoscopy..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was reported that patient was not part of any clinical trial study for Covid 19 vaccine. Formulation of Humira was reported as 40 Milligram, Solution for injection in pre-filled syringe. The reporter causality for the events of Colonic polyp, Asthmatic attack was assessed as Not related for suspect Humira. The manufacturer causality for the events of Colonic polyp, Asthmatic attack was assessed as  Reasonable possibility and No Reasonable possibility for suspect humira. The patient had been having colonoscopy every three years because she had family predisposition for colon problems.  On 07 Oct 2021, three polyps were found and was removed during the colonoscopy. The procedure was done in an outpatient setting and she was sent home the same day. 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.  Company comment.  This spontaneous case concerns a 75  year  old, female patient, with family history of gastrointestinal disorders (described as "colon problems"), who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant event of large intestine polyp, which occurred the same year as vaccination. Exact vaccination date was not reported; hence latency and temporal association cannot be properly assessed. The patient had been having colonoscopy every three years because she had family predisposition for colon problems, and in October 2021 three polyps were found and removed. No further details were provided for medical reviewing. Patient´s age and mentioned family history remains as risk factor for large intestine polyp. Co  suspect product Adalimumab remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75  year  old, female patient, with family history of gastrointestinal disorders (described as "colon problems"), who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant event of large intestine polyp, which occurred the same year as vaccination. Exact vaccination date was not reported; hence latency and temporal association cannot be properly assessed. The patient had been having colonoscopy every three years because she had family predisposition for colon problems, and in October 2021 three polyps were found and removed. No further details were provided for medical reviewing. Patient´s age and mentioned family history remains as risk factor for large intestine polyp. Co  suspect product Adalimumab remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.