Age: 92.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Fall, SARS-CoV-2 test
Clinical narrative: Fall; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) in a 91-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 ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and 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) 1 dosage form. In February 2022, the patient experienced FALL (Fall) (seriousness criterion hospitalization). In 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with Rehabilitation therapy for Fall. At the time of the report, FALL (Fall) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Patient was tested positive while in hospital.  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 91 year old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Fall and unexpected non serious  of COVID-19, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient completed the primary series of vaccination (schedule unknown) with no reported adverse events. SARS-CoV-2 test was positive on an unknown date. No further information on detailed clinical course, investigations and treatment was available in the report. The events were resolving. Advanced age and co suspect adalimumab could be a risk factor for the events. COVID-19 pandemia could be confounding for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 91 year old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Fall and unexpected non serious of COVID-19, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient completed the primary series of vaccination (schedule unknown) with no reported adverse events. SARS-CoV-2 test was positive on an unknown date. No further information on detailed clinical course, investigations and treatment was available in the report. The events were resolving. Advanced age and co suspect adalimumab could be a risk factor for the events. COVID-19 pandemia could be confounding for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.