Age: 24.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Clammy; Shiverring; Vaccination site pain; Crohn's disease aggravated; Inflammatory marker increased; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 24-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) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) Citrate Free. In November 2021, the patient experienced INFLAMMATORY MARKER INCREASED (Inflammatory marker increased). In December 2021, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced COLD SWEAT (Clammy), CHILLS (Shiverring) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated), INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), COLD SWEAT (Clammy), CHILLS (Shiverring) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Inflammatory marker test: INFLAMMATION MARKERS ELEVATED.         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. HAEMATOCHEZIA (Blood in stool), DIARRHOEA HAEMORRHAGIC (Bloody diarrhea), Weight loss, Nauseous, Vomiting, Appetite lost, Fatigue, Abdominal cramp were the reported symptoms related to Crohn's disease flare up. It was mentioned that patient was sick.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company comment; This spontaneous case concerns a 24-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided), who experienced the unexpected serious (medically significant) event of Crohn's disease aggravated on an unspecified date. Patient received 2 doses of mRNA-1273 vaccine on unknown dates. Patient got sick, felt clammy, with nausea and vomiting after firs COVID vaccination, and shivering on second vaccination. In November 2021, inflammatory markers were noted to be elevated. Approximately one month later, the patient experienced Crohn's disease flare-up symptoms such as loss of appetite, weight loss, fatigue, bloody diarrhea, blood in stool, and abdominal cramping. Clinical course was not reported. The outcome of event was reported as unknown. Adalimumab indicated for Crohn's disease could be a confounder for the case as the said disease flares up. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant follow up appended.; Sender's Comments: This spontaneous case concerns a 24-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided), who experienced the unexpected serious (medically significant) event of Crohn's disease aggravated on an unspecified date. Patient received 2 doses of mRNA-1273 vaccine on unknown dates. Patient got sick, felt clammy, with nausea and vomiting after firs COVID vaccination, and shivering on second vaccination. In November 2021, inflammatory markers were noted to be elevated. Approximately one month later, the patient experienced Crohn's disease flare-up symptoms such as loss of appetite, weight loss, fatigue, bloody diarrhea, blood in stool, and abdominal cramping. Clinical course was not reported. The outcome of event was reported as unknown. Adalimumab indicated for Crohn's disease could be a confounder for the case as the said disease flares up. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement.