Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nasal operation
Clinical narrative: Four nasal surgeries; Patient received first dose of Moderna vaccine on 09-Feb-2021 and second dose of Moderna vaccine on 26-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of NASAL OPERATION (Four nasal surgeries) in a 56-year-old male 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.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second 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) Citrate free. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 09-Feb-2021 and second dose of Moderna vaccine on 26-Mar-2021). In October 2021, the patient experienced NASAL OPERATION (Four nasal surgeries) (seriousness criterion medically significant). At the time of the report, NASAL OPERATION (Four nasal surgeries) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 09-Feb-2021 and second dose of Moderna vaccine on 26-Mar-2021) outcome was unknown.            Company comment: This is a spontaneous case concerning a 56-year-old male patient with Chron´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Nasal operation. It was reported that patient had 4 nasal surgeries since October 2021, approximately 6 months after the second dose of mRNA-1273.  Very limited information regarding the event has been reported.  Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. Inappropriate schedule of product administration was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for event four nasal surgeries with co-suspect Humira 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.   This case was linked to MOD-2022-624383 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 56-year-old male patient with Chron´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Nasal operation. It was reported that patient had 4 nasal surgeries since October 2021, approximately 6 months after the second dose of mRNA-1273.  Very limited information regarding the event has been reported.  Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. Inappropriate schedule of product administration was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.