Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Post procedural erythema, Post procedural infection
Clinical narrative: Postoperative infection; Post procedural erythema; Inappropriate schedule of vaccine administered; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL INFECTION (Postoperative infection), POST PROCEDURAL ERYTHEMA (Post procedural erythema) and FATIGUE (Fatigue) 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 product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced POST PROCEDURAL INFECTION (Postoperative infection) (seriousness criterion medically significant), POST PROCEDURAL ERYTHEMA (Post procedural erythema) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, POST PROCEDURAL INFECTION (Postoperative infection), POST PROCEDURAL ERYTHEMA (Post procedural erythema), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided          The concomitant medication was not reported by reporter. The patient had right knee replacement on 11-Jan-2022. It got infected and was still red. It was unknown if she was enrolled in a COVID-19 vaccine trial. She had fatigue following both COVID-19 vaccines. Adverse event information provided by her was related to COVID-19 vaccine. No treatment medication was 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.  Company comment: This spontaneous case concerns a 55 year old female patient with concurrent condition of rheumatoid arthritis and history of right knee replacement, who experienced the unexpected serious (medically significant) events of Post procedural infection, Post procedural erythema, in about 5 months ; and Fatigue, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine in about 2 months.  Inappropriate schedule of product administration was noted. No information on exact dates of events and vaccination schedule, detailed clinical course, reports of relevant investigations and treatment details was available in the report. Co-suspect Upadacitinib could be a risk factor for the event Post procedural infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-620294 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55 year old female patient with concurrent condition of rheumatoid arthritis and history of right knee replacement, who experienced the unexpected serious (medically significant) events of Post procedural infection, Post procedural erythema, in about 5 months ; and Fatigue, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine in about 2 months.  Inappropriate schedule of product administration was noted. No information on exact dates of events and vaccination schedule, detailed clinical course, reports of relevant investigations and treatment details was available in the report. Co-suspect Upadacitinib could be a risk factor for the event Post procedural infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.