Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Colitis, Colon injury, Colonoscopy, SARS-CoV-2 test
Clinical narrative: Covid-19; sigmoidoscopy in November of 2021 which showed quiescent colitis that she said means that they saw structural damage to her colon but not active inflammation; quiescent colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLON INJURY (sigmoidoscopy in November of 2021 which showed quiescent colitis that she said means that they saw structural damage to her colon but not active inflammation), COLITIS (quiescent colitis) and COVID-19 (Covid-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 002B21A and 024M20A) for COVID-19 vaccination.     Patient had no history of a positive Covid test until 26Apr2022.  Concomitant products included PREDNISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COLON INJURY (sigmoidoscopy in November of 2021 which showed quiescent colitis that she said means that they saw structural damage to her colon but not active inflammation) and COLITIS (quiescent colitis). On 26-Apr-2022, the patient experienced COVID-19 (Covid-19). The patient was treated with MESALAMINE in July 2021 for Colitis, at a dose of 1 dosage form. At the time of the report, COLON INJURY (sigmoidoscopy in November of 2021 which showed quiescent colitis that she said means that they saw structural damage to her colon but not active inflammation), COLITIS (quiescent colitis) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2022, Colonoscopy: structural damage to her colon but not active infl structural damage to her colon but not active inflammation. On 26-Apr-2022, SARS-CoV-2 test: positive (Positive) positive.         It was reported that the patient took full 3rd dose.  Patient stated that she also now had lumps on her leg that were called erythema nodosum that started in September of 2021 which doctor said were related to the colon inflammation. She said the lumps move around, were the size of big mosquito bites, were hard, & form between the bones & skin.  Treatment information included Pancrelipase for pancreatic insufficiency  Company comment: This spontaneous case concerns an 87-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events), approximately 5 months after the third dose of mRNA-1273 vaccine. A positive SARS- CoV-2 test was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an 87-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events), approximately 5 months after the third dose of mRNA-1273 vaccine. A positive SARS- CoV-2 test was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.