Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crohn's disease, Inappropriate schedule of product administration
Clinical narrative: Crohns disease flare up; Left knee hurting/knees had some pain; 1st Dose 1-Jan-2022 and 2nd Dose-15-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease flare up) in a 71-year-old female patient who received mRNA-1273 (Spikevax) 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.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE.).   On 01-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On 15-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose 1-Jan-2022 and 2nd Dose-15-Feb-2022). On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flare up) (seriousness criterion medically significant) and ARTHRALGIA (Left knee hurting/knees had some pain). At the time of the report, CROHN'S DISEASE (Crohns disease flare up) had resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose 1-Jan-2022 and 2nd Dose-15-Feb-2022) outcome was unknown and ARTHRALGIA (Left knee hurting/knees had some pain) had not resolved.            No concomitant medications were reported.  Co-suspect drug Humira's formulation was solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events arthralgia and crohn's disease was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  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 71-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 45 days between doses, and experienced medically significant event of Crohn's disease aggravated. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of arthralgia. Crohn's disease can flare as part of its natural history. Adalimumab could be a contributory factor for arthralgia. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-621409 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Follow-up received wherein case upgraded to serious, patient's demographic updated, new event added. Co-suspect drug information and narrative description updated.; Sender's Comments: This is a spontaneous case reported by a consumer. A 71-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 45 days between doses, and experienced medically significant event of Crohn's disease aggravated. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of arthralgia. Crohn's disease can flare as part of its natural history. Adalimumab could be a contributory factor for arthralgia. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.