Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Peripheral swelling, Pruritus
Clinical narrative: puss coming out of her leg; Blood coming out of her leg; cellulitis; leg was red; leg was itchy; left leg swollen, leg got so big it looked like it could burst,left foot swollen; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis), ABSCESS LIMB (puss coming out of her leg) and HAEMORRHAGE (Blood coming out of her leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Agent felt her speech was not clear so it was hard at times to understand some details.) in 2005 and Cellulitis in 2013. Concomitant products included HYDROCHLOROTHIAZIDE, CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and IRBESARTAN (AVAPRO) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced PERIPHERAL SWELLING (left leg swollen, leg got so big it looked like it could burst,left foot swollen). In July 2021, the patient experienced BACK PAIN (back pain). On 16-Jul-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ABSCESS LIMB (puss coming out of her leg) (seriousness criterion hospitalization), HAEMORRHAGE (Blood coming out of her leg) (seriousness criteria hospitalization and medically significant), ERYTHEMA (leg was red) and PRURITUS (leg was itchy). The patient was hospitalized on 16-Jul-2021 due to ABSCESS LIMB, CELLULITIS and HAEMORRHAGE. The patient was treated with MULTIVITAMIN [VITAMINS NOS] at a dose of 1 dosage form and LINEZOLID for Redness and Swelling, at a dose of 1 dosage form. At the time of the report, CELLULITIS (cellulitis), ABSCESS LIMB (puss coming out of her leg), HAEMORRHAGE (Blood coming out of her leg), BACK PAIN (back pain), PERIPHERAL SWELLING (left leg swollen, leg got so big it looked like it could burst,left foot swollen), ERYTHEMA (leg was red) and PRURITUS (leg was itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Hepatic enzyme: high (High) Liver enzymes up.         Patient has tried a few other antibiotics and ended up having a bad allergic reaction, not sure which one, so they took her off both.  Very limited information regarding these events have been provided at this time. Other factors could have contributed to the events, as there was a very long latency from the start of the event and date of last dose of vaccine. No further information is expected.   This case was linked to MOD-2021-037218 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Other factors could have contributed to the events, as there was a very long latency from the start of the event and date of last dose of vaccine. No further information is expected.