Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Large intestine polyp, Myalgia
Clinical narrative: four colon polyps; Generalized aching; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINE POLYP (four colon polyps) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Colonoscopy (four poylps were removed) on 16-Jul-2021. Family history included Asthma (Patient had a family history of asthma but no history of colon polyps.) since an unknown date. Concurrent medical conditions included Migraine, Abstains from alcohol and Crohn's disease. Concomitant products included PARACETAMOL (TYLENOL) for Migraine.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced MYALGIA (Generalized aching). On 16-Jul-2021, the patient experienced LARGE INTESTINE POLYP (four colon polyps) (seriousness criterion medically significant). In July 2021, LARGE INTESTINE POLYP (four colon polyps) had resolved. On 17-Jul-2021, MYALGIA (Generalized aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. No known allergies were reported.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. The patient was able to recover about two to three days after the procedure. There was biopsy done but no result yet. Patient had body aches after second dose of COVID vaccine but now was doing well. No treatment medications were reported.  Company comment: This spontaneous case concerns a 22-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of large intestine polyp 2 days after the second dose of mRNA-1273. The patient underwent a colonoscopy where 4 colonic polyps were removed (biopsy report was still pending). The medical history of Crohn's disease is a risk factor for the event. Outcome was reported as recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow up received: medical history, drug start date, event outcome was updated; Sender's Comments: This spontaneous case concerns a 22-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of large intestine polyp 2 days after the second dose of mRNA-1273. The patient underwent a colonoscopy where 4 colonic polyps were removed (biopsy report was still pending). The medical history of Crohn's disease is a risk factor for the event. Outcome was reported as recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.