Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Scar, Vaccination site pain
Clinical narrative: Surgical scar; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (Surgical scar) in a 58-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.    There was no reported medical history.  Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced SCAR (Surgical scar) (seriousness criterion medically significant), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SCAR (Surgical scar) had not resolved and FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            It was reported that, the patient had lot of scar tissue due to surgery, felt fatigued and had a sore arm.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient had surgery to remove scar tissue on 09-Dec-2021.  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 spontaneous case reported by a consumer, concerns a 58 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of SCAR (Surgical scar) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received 2 primary doses with Janssen vaccine, with no adverse events reported. Interchange of vaccine products was noted. On an unknown date, the patient had received Upadacitinib for Rheumatoid arthritis. The patient had surgery to remove scar tissue. It was reported that, the patient had lot of scar tissue due to surgery. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had not. resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns a 58 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of SCAR (Surgical scar) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received 2 primary doses with Janssen vaccine, with no adverse events reported. Interchange of vaccine products was noted. On an unknown date, the patient had received Upadacitinib for Rheumatoid arthritis. The patient had surgery to remove scar tissue. It was reported that, the patient had lot of scar tissue due to surgery. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.