Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium test, Crohn's disease, Giardia test, Influenza like illness, Weight
Clinical narrative: Crohn's disease aggravated/Diarrhea; Flu like symptoms/Fatigue/Headache; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated/Diarrhea) and INFLUENZA LIKE ILLNESS (Flu like symptoms/Fatigue/Headache) in a 56-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) for Crohn's disease.    The patient's past medical history included Crohn's disease. Concurrent medical conditions included Hyperthyroidism, Blood pressure high, Cholesterol high and Overweight (BMI OVER 30).   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated/Diarrhea) (seriousness criteria hospitalization and medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms/Fatigue/Headache) (seriousness criterion hospitalization). The patient was hospitalized from 10-Feb-2022 to sometime in 2022 due to CROHN'S DISEASE and INFLUENZA LIKE ILLNESS. The patient was treated with SEMAGLUTIDE (WEGOVY) at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated/Diarrhea) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like symptoms/Fatigue/Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Clostridium test: (Negative) Negative. In February 2022, Giardia test: (Negative) Negative. On an unknown date, Weight: Decreased.         No concomitant medications was reported.  On 10-Feb-2022, the patient was hospitalized for the events. Physician prescribed wegovy for weight loss. Patient had flu like symptom and fatigue. Physician prescribed steroids to help with recovery. On 2022, the was patient was discharged from hospital.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 concerns a female patient aged 56 years with relevant medical history of Crohn's disease on Humira reported, who experienced the unexpected serious (medically significant/hospitalization) event of CROHN'S DISEASE(Crohn's disease aggravated), unexpected serious (hospitalization) event of Influenza like illness that occurred in the context of mRNA-1273 vaccination (booster dose). Latency cannot be assessed since vaccination date was not disclosed. Patient was hospitalized on 10-Feb-2022 for diarrhoea tested negative for giardia and C.difficile. she had Crohn's flareup she also had flu like symptoms. She was prescribed steroids for recovery. Outcome of the event Crohn's disease aggravated was not known while Influenza like illness had resolved at the time of report. Relevant medical history remains a confounder to the event Crohn's disease aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 56 years with relevant medical history of Crohn's disease on Humira reported, who experienced the unexpected serious (medically significant/hospitalization) event of CROHN'S DISEASE(Crohn's disease aggravated), unexpected serious (hospitalization) event of Influenza like illness that occurred in the context of mRNA-1273 vaccination (booster dose). Latency cannot be assessed since vaccination date was not disclosed. Patient was hospitalized on 10-Feb-2022 for diarrhoea tested negative for giardia and C.difficile. she had Crohn's flareup she also had flu like symptoms. She was prescribed steroids for recovery. Outcome of the event Crohn's disease aggravated was not known while Influenza like illness had resolved at the time of report. Relevant medical history remains a confounder to the event Crohn's disease aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement