Age: 55.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, Cyst, SARS-CoV-2 test
Clinical narrative: cyst underneath her arm removal; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CYST (cyst underneath her arm removal) in a 55-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 products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and ADALIMUMAB (HUMIRA) for Crohn's disease.    No illicit drug use.  Concurrent medical conditions included Crohn's disease since 1982, Non-tobacco user (No tobacco use) and Ex-alcoholic (No alcohol use).   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-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) 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 11-May-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CYST (cyst underneath her arm removal) (seriousness criterion hospitalization). At the time of the report, CYST (cyst underneath her arm removal) was resolving and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was provided. Treatment medication was not provided by the reporter.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On 11 May 2021, the patient contracted covid after pausing Humira therapy and after getting her first dose of the covid vaccine. She was hospitalized for a for cyst underneath her arm removal.  The reporter's causality for humira 40mg/0.4ml(adalimumab) for the event(s) of cyst underneath arm and acquired/contracted covid was not provided.  The reporter's causality for humira (adalimumab) for the event(s) of cyst underneath arm was not provided. the reporter's causality for the event(s) of acquired/contracted covid with humira(adalimumab) was no reasonable possibility.  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 55-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (hospitalization) of Cyst and unexpected non-serious AESI of COVID-19. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on 11-May-2021. The Clinical course, Concomitant medication and treatment details were not provided, and the event cyst outcome was resolving, and COVID-19 was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Significant follow up was received. Patient height and weight added.medical history updated; Sender's Comments: This spontaneous case concerns a 55-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (hospitalization) of Cyst and unexpected non-serious AESI of COVID-19. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on 11-May-2021. The Clinical course, Concomitant medication and treatment details were not provided, and the event cyst outcome was resolving, and COVID-19 was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.