Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Gait disturbance, Lymphadenopathy, Lymphoedema, Product dose omission issue
Clinical narrative: T12 compression fracture/ Back broke; Can not walk without a walker/ Can not go upstairs; Has not received 2nd shot/ More than 5 months after first vaccine; Swollen lymph nodes in the legs; Cellulitis; Lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of THORACIC VERTEBRAL FRACTURE (T12 compression fracture/ Back broke) and CELLULITIS (Cellulitis) in a 68-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.     The patient's past medical history included Ankle swelling (Left ankle swelled up) in October 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced THORACIC VERTEBRAL FRACTURE (T12 compression fracture/ Back broke) (seriousness criteria hospitalization and medically significant) and LYMPHADENOPATHY (Swollen lymph nodes in the legs). In April 2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and LYMPHOEDEMA (Lymphedema). On an unknown date, the patient experienced GAIT DISTURBANCE (Can not walk without a walker/ Can not go upstairs) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd shot/ More than 5 months after first vaccine). The patient was hospitalized on sometime in April 2021 due to THORACIC VERTEBRAL FRACTURE. The patient was treated with Rehabilitation therapy for Thoracic vertebral fracture. At the time of the report, THORACIC VERTEBRAL FRACTURE (T12 compression fracture/ Back broke), CELLULITIS (Cellulitis), LYMPHOEDEMA (Lymphedema), GAIT DISTURBANCE (Can not walk without a walker/ Can not go upstairs) and LYMPHADENOPATHY (Swollen lymph nodes in the legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd shot/ More than 5 months after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. Previous to vaccination, the patient was tested for blood clot which came negative.  On 14-Apr-2021, the patient's back broke (T12 compression fracture) and visited an emergency room where they did X-Ray.  On an unknown date, the patient was moved to a rehab where the patient got cellulitis and lymphedema.  The patient was currently at home but can not walk without a walker and can not go upstairs, feet were big and had swollen lymph nodes in the legs only. The patient had not received the second shot.  Company comment This case concerns a 68-year-old female patient with no relevant medical history, who experienced the serious  unexpected event Thoracic vertebral fracture and celulitis. The events occurred approximately 20 days after the first dose  of mRNA-1273 Moderna vaccine.  Product dose omission issue was already captured as an event, as patient has not received second dose. Thus, rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old female patient with no relevant medical history, who experienced the serious  unexpected event Thoracic vertebral fracture and celulitis. The events occurred approximately 20 days after the first dose  of mRNA-1273 Moderna vaccine.  Product dose omission issue was already captured as an event, as patient has not received second dose. Thus, rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.