Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonic abscess, Diarrhoea, Headache, Stress
Clinical narrative: Colon abscess; Little stress; Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COLONIC ABSCESS (Colon abscess) in an elderly 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) solution for injection for Crohn's disease and Rheumatoid arthritis.    The patient's past medical history included Colonic abscess and Colon operation (about ten years ago due to abscess).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced COLONIC ABSCESS (Colon abscess) (seriousness criterion medically significant), STRESS (Little stress), DIARRHOEA (Diarrhea) and HEADACHE (Headache). The patient was treated with Surgery for Headache. At the time of the report, COLONIC ABSCESS (Colon abscess) outcome was unknown and STRESS (Little stress), DIARRHOEA (Diarrhea) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Results were ok.         No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. The patient had been having excessive diarrhea, she saw doctor for blood test and the results were ok.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the event colon abscess, little stress, diarrhea and headache with co-suspect Humira was not 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.  Company comment  This spontaneous case reported by a consumer, concerns a female patient of unknown age, with relevant medical history of colonic abscess and had underwent colonic surgery 10 years ago, who experienced the unexpected, serious (medically significant) event of Colonic abscess, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious event of Stress, Diarrhoea and headache. Patient had previously received the 2 primary doses with Moderna vaccine with no adverse events reported. It was reported that the patient received Adalimumab for Chron's Disease and Rheumatoid Arthritis. The patient had been having excessive diarrhea, blood tests were normal. Past history of colonic abscess requiring surgery, Excessive Diarrhoea and use of Adalimumab are confounders. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up includes significant information: Patient age group updated and event Excessive Diarrhea was amended to Diarrhea.; Sender's Comments: This spontaneous case reported by a consumer, concerns a female patient of unknown age, with relevant medical history of colonic abscess and had underwent colonic surgery 10 years ago, who experienced the unexpected, serious (medically significant) event of Colonic abscess, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious event of Stress, Diarrhoea and headache. Patient had previously received the 2 primary doses with Moderna vaccine with no adverse events reported. It was reported that the patient received Adalimumab for Chron's Disease and Rheumatoid Arthritis. The patient had been having excessive diarrhea, blood tests were normal. Past history of colonic abscess requiring surgery, Excessive Diarrhoea and use of Adalimumab are confounders. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.