Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Breast inflammation, Intentional product use issue, Seasonal allergy, Skin ulcer
Clinical narrative: have all kind of allergies now to the trees; Breast biopsy due to inflamed tissue; agitated; Intentional deviation from dosage regimen; every now and then they get venous stasis ulcer / the wound on her left leg opened up; wound on her left leg opened up; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ULCER (every now and then they get venous stasis ulcer / the wound on her left leg opened up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Venous insufficiency (valve is not able pump  blood  back to the heart properly) and Venous stasis ulcer (blood sits there and dies causes it open up and takes 6 months to heal). Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SKIN ULCER (every now and then they get venous stasis ulcer / the wound on her left leg opened up) (seriousness criterion medically significant), WOUND (wound on her left leg opened up) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). On an unknown date, the patient experienced SEASONAL ALLERGY (have all kind of allergies now to the trees), BREAST INFLAMMATION (Breast biopsy due to inflamed tissue ) and AGITATION (agitated). In January 2021, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) had resolved. In July 2021, SKIN ULCER (every now and then they get venous stasis ulcer / the wound on her left leg opened up) had resolved, WOUND (wound on her left leg opened up) outcome was unknown. At the time of the report, SEASONAL ALLERGY (have all kind of allergies now to the trees), BREAST INFLAMMATION (Breast biopsy due to inflamed tissue ) and AGITATION (agitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.  Patient stated the wound stated open for 6 months until July. Patient was working during the time, going to wound care once a week, $1000 in copay, and disturbing normal life. Patient stated that they had 6 months of pain. Patient stated causing her not able to walk which has not happen before.  Company Comment: This case concerns a 56-year-old male patient with a previous relevant medical history of Venous insufficiency and venous static ulcers, who experienced the serious unexpected event of Venous ulcer recurrent after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, intentional deviation from dosage regimen was captured. The onset of the event occurred approximately 3 weeks after the first dose of Spikevax. Clinical manifestations included the wound opening, pain, gait inability and disturbance in daily activities. The patient received weekly medical treatment and the event resolved after 6 months. The rechallenge is unknown since only information about the first dose was disclosed. Underlying venous insufficiency and previous history of venous static ulcers remain a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.; Sender's Comments: This case concerns a 56-year-old male patient with a previous relevant medical history of Venous insufficiency and venous static ulcers, who experienced the serious unexpected event of Venous ulcer recurrent after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, intentional deviation from dosage regimen was captured. The onset of the event occurred approximately 3 weeks after the first dose of Spikevax. Clinical manifestations included the wound opening, pain, gait inability and disturbance in daily activities. The patient received weekly medical treatment and the event resolved after 6 months. The rechallenge is unknown since only information about the first dose was disclosed. Underlying venous insufficiency and previous history of venous static ulcers remain a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.