Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Had a bruise on their leg, and it grow; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Had a bruise on their leg, and it grow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 039k20-2a, 013L20A and 939902) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Stent insertion NOS and Leg amputation (Patient had to get their leg amputated after 30 days of getting the four shot) on 21-Jun-2022. Concurrent medical conditions included Diabetes. Concomitant products included OXYCODONE, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID], PREDNISONE, AMLODIPINE, SENNA ALEXANDRINA LEAF (SENNA [SENNA ALEXANDRINA LEAF]) and CLOPIDOGREL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONTUSION (Had a bruise on their leg, and it grow) (seriousness criterion hospitalization). At the time of the report, CONTUSION (Had a bruise on their leg, and it grow) had not resolved.            Patient also taking concomitant medications like high blood pressure medicine, cholesterol medicine, heart medicine and depression medicine. Patient was not sure if third shot was a third dose or booster and fourth shot was a full shot or booster. Reporter said that the four shot did a good job protecting against Covid. She never had COVID + test or diagnosis. Patient had not taken any other vaccines given within 1 month prior to Moderna COVID-19 vaccine and had not experienced a similar event in the past. She was hospitalized for over weeks. Her symptoms got worsened. Patient was hospitalized over to weeks. Patient had no history related to mentioned AE or Acute or Chronic illnesses at the time of vaccination. Treatment information was not reported.  Company comment: This spontaneous case concerns a 66 year old female, with current condition of diabetes mellitus and underlying medical procedure of leg amputation, who experienced the unexpected, serious (hospitalization) event of Contusion (described as had a bruise on their leg and it grow) which occurred 2 days after receiving the fourth dose of mRNA1273. It was reported that 2 days after getting the four shot they had a bruise on their leg, and it grow. Eventually the patient had leg amputation 30 days after fourth vaccination. Further details regarding the clinical course were not provided. The patient's elderly age and concurrent diabetes mellitus may be considered as both contributory and risk factors to contusion, while the medical procedure leg amputation may be in association with the event as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66 year old female, with current condition of diabetes mellitus and underlying medical procedure of leg amputation, who experienced the unexpected, serious (hospitalization) event of Contusion (described as had a bruise on their leg and it grow) which occurred 2 days after receiving the fourth dose of mRNA1273. It was reported that 2 days after getting the four shot they had a bruise on their leg, and it grow. Eventually the patient had leg amputation 30 days after fourth vaccination. Further details regarding the clinical course were not provided. The patient's elderly age and concurrent diabetes mellitus may be considered as both contributory and risk factors to contusion, while the medical procedure leg amputation may be in association with the event as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.