Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of SKIN MASS (increase in size on of the areas some nodules/On 6/9/2021 visit small nodules were palpated on the right cheek / All nodules were palpable but not visible and under 3mm in size /areas have continued to increase in size and number since September 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product POLY-L-LACTIC ACID (SCULPTRA) for an unknown indication. No Medical History information was reported. On 15-Sep-2020, the patient started POLY-L-LACTIC ACID (SCULPTRA) (unknown route) 1 at a time with about 8 weeks (7th session). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced SKIN MASS (increase in size on of the areas some nodules/On 6/9/2021 visit small nodules were palpated on the right cheek / All nodules were palpable but not visible and under 3mm in size /areas have continued to increase in size and number since September 2021). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (intralesional) at an unspecified dose and frequency. At the time of the report, SKIN MASS (increase in size on of the areas some nodules/On 6/9/2021 visit small nodules were palpated on the right cheek / All nodules were palpable but not visible and under 3mm in size /areas have continued to increase in size and number since September 2021) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient looks like she had HIV related lipoatrophy but she did not, likely just extremely low body weight/fat. At her 7th session of Sculptra on 09-Jun-2021, there were 2 very small non tender palpable nodules that were noted. The patient always do 1 vial at a time. When physician saw her about 6 weeks later the nodules were larger and physician decided not to do any further Sculptra. Physician did several sessions of ILK which did not resolve the areas but did keep them from growing. They decided to watch and wait since they were not tender or growing, and not visible from the outside but when physician saw her back a few weeks ago the areas had grown in size on the right cheek and were now visible when the skin was stretched. Physician did another session of ILK, but she was very concerned that they would not resolve without excision. On an unknown date the patient had an intralesional injection of Kenalog with saline. with no resolution of the areas but no progression. Patient had Sculptra single vials administered in the office on the following dates: 15 Sep 2020, 30 Oct 2020, 11 Dec 2020, 20 Jan 2021, 10 Mar 2021, 20 Apr 2021, 09 Jun 2021 (Last session of Sculptra). On 09 Jun 2021 visit small nodules were palpated on the right cheek, this cheek was avoided during injection. Over next few months patient had increase in size on of these areas and some nodules now on the left. All nodules were palpable but not visible and under 3mm in size. Over the next 9 months the areas grew somewhat in size, never tender or erythematous, difficult to assess externally without distention of the skin. The areas have continued to increase in size and number since September 2021. These type of nodules can be seen in patients receiving Sculptra, which was discussed with patients on consent forms, and there were known reports of this in the literature unrelated to COVID vaccination. This case was linked to MOD-2022-509992 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up contains significant information. Patients Race information updated, Concomitant updated to co-suspect, administration date updated narrative supplement updated.