Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Knee arthroplasty
Clinical narrative: Total knee replacement; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Total knee replacement) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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) at an unspecified dose. On 15-Feb-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced KNEE ARTHROPLASTY (Total knee replacement) (seriousness criterion medically significant). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, KNEE ARTHROPLASTY (Total knee replacement) was resolving.            No concomitant medications were reported. Patient experienced non-serious events of right knee replaced and felt fatigued with HUMIRA (ADALIMUMAB).  The patient had surgery and right knee replaced. She had first COVID-19 vaccine and she felt fatigued.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of right knee replaced with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's causality for the event(s) of felt fatigue was not provided.  No treatment medications information were 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 reported by a consumer, concerns a 75 year old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) events of KNEE ARTHROPLASTY (Total knee replacement) and fatigue unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient had previously received the 1 dose with Moderna  vaccine about 1 month ago . It was reported that She felt fatigued after she had the first COVID-19 vaccine. Fatigue had resolved. The patient had surgery and right knee was replaced and the event was resolving.  On an unknown date, the patient started ADALIMUMAB (HUMIRA) for ulcerative colitis, which could be considered as a confounder for fatigue.  Patient felt fatigued and had the right knee replaced after taking Humira. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. 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 75 year old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) events of KNEE ARTHROPLASTY (Total knee replacement) and fatigue unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient had previously received the 1 dose with Moderna  vaccine about 1 month ago .It was reported that She felt fatigued after she had the first COVID-19 vaccine. Fatigue had resolved. The patient had surgery and right knee was replaced and the event was resolving.  On an unknown date, the patient started ADALIMUMAB (HUMIRA) for ulcerative colitis, which could be considered as a confounder for fatigue.  Patient felt fatigued and had the right knee replaced after taking Humira. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.