Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Chronic diarrhea; SORE ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Chronic diarrhea) in a 56-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 Rheumatoid arthritis.    The patient's past medical history included Surgery (Botched surgery from 30 years ago.) in 1992. Concurrent medical conditions included Diarrhoea (Since 1992, the patient had ongoing diarrhea that had gotten worse in 2022.) since 1992, Rheumatoid arthritis and Depression.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) daily. In November 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE). On an unknown date, the patient experienced DIARRHOEA (Chronic diarrhea) (seriousness criterion medically significant). In November 2021, VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) had resolved. At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of constant Diarrhea and Co-suspect drug Humira, who experienced the unexpected serious (medically significant) event of Diarrhea aggravated, and the expected event of Vaccination site pain. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for vaccination site pain and not resolved for Diarrhea. The patient's medical history of constant Diarrhea and Co-suspect drug Humira, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-584794, MOD-2022-584795 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of constant Diarrhea and Co-suspect drug Humira, who experienced the unexpected serious (medically significant) event of Diarrhea aggravated, and the expected event of Vaccination site pain. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for vaccination site pain and not resolved for Diarrhea. The patient's medical history of constant Diarrhea and Co-suspect drug Humira, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.