Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dairy intolerance, Diarrhoea, Vaccination site pain
Clinical narrative: Dairy intolerance; Diarrhoea; Vaccination site pain; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DAIRY INTOLERANCE (Dairy intolerance), COVID-19 (COVID-19), DIARRHOEA (Diarrhoea) and VACCINATION SITE PAIN (Vaccination site pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No other Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In August 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DAIRY INTOLERANCE (Dairy intolerance), DIARRHOEA (Diarrhoea) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DAIRY INTOLERANCE (Dairy intolerance) and DIARRHOEA (Diarrhoea) was resolving and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.  On unknown date, the patient experienced diarrhoea when eating dairy and vaccine caused sore arm. In August 2021, the patient experienced Covid. On unknown date, Covid and vaccine caused sore arm resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of diarrhoea when eating dairy, diarrhoea when eating dairy, covid and vaccine caused sore arm 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 is a spontaneous case reported by a consumer. A 44-year-old female patient, with concurrent condition of Crohn's disease, experienced non serious event of COVID-19 (AESI)approximately 5 months after receiving first dose of mRNA-1273 vaccine. In addition, on an unknown date, patient experienced non serious events of vaccination site pain, dairy intolerance and diarrhoea. No further details regarding second dose, clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of Crohn's disease could be a contributory factor for dairy intolerance and diarrhoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 44-year-old female patient, with concurrent condition of Crohn's disease, experienced non serious event of COVID-19 (AESI)approximately 5 months after receiving first dose of mRNA-1273 vaccine. In addition, on an unknown date, patient experienced non serious events of vaccination site pain, dairy intolerance and diarrhoea. No further details regarding second dose, clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of Crohn's disease could be a contributory factor for dairy intolerance and diarrhoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.