Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin induration, Skin mass, Skin plaque, Vaccination complication
Clinical narrative: noticed very thick lumpy plaques under skin of cheeks where sculptra had been injected; Fever of 100 to 100.5; Total fatigue; Chills; Muscle aches; Scluptra feels hard in her face; immediately after 2nd shot she had a bad reaction; Lumps at site of facial fillers cheeks/ looks like marbles were under her skin; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021. The most recent information was received on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN INDURATION (Scluptra feels hard in her face), VACCINATION COMPLICATION (immediately after 2nd shot she had a bad reaction), SKIN MASS (Lumps at site of facial fillers cheeks/ looks like marbles were under her skin), SKIN PLAQUE (noticed very thick lumpy plaques under skin of cheeks where sculptra had been injected) and PYREXIA (Fever of 100 to 100.5) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included MS in June 2001, Asthma in 1960, Ulcerative colitis, Colectomy (Age 25) and Dermal filler injection. Concurrent medical conditions included Drug allergy (Allergy to NSAIDS). Concomitant products included GLATIRAMER from 2001 to an unknown date for MS, MODAFINIL (PROVIGIL [MODAFINIL]) from 2001 to an unknown date and VITAMIN D NOS from 2015 to an unknown date for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN MASS (Lumps at site of facial fillers cheeks/ looks like marbles were under her skin). On an unknown date, the patient experienced SKIN INDURATION (Scluptra feels hard in her face), VACCINATION COMPLICATION (immediately after 2nd shot she had a bad reaction), SKIN PLAQUE (noticed very thick lumpy plaques under skin of cheeks where sculptra had been injected), PYREXIA (Fever of 100 to 100.5), FATIGUE (Total fatigue), CHILLS (Chills) and MYALGIA (Muscle aches). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 12-May-2021 for Adverse reaction, at an unspecified dose and frequency and LIDOCAINE on 12-May-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN INDURATION (Scluptra feels hard in her face), VACCINATION COMPLICATION (immediately after 2nd shot she had a bad reaction), PYREXIA (Fever of 100 to 100.5), FATIGUE (Total fatigue), CHILLS (Chills) and MYALGIA (Muscle aches) outcome was unknown and SKIN MASS (Lumps at site of facial fillers cheeks/ looks like marbles were under her skin) and SKIN PLAQUE (noticed very thick lumpy plaques under skin of cheeks where sculptra had been injected) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: increased (High) 100-100.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had been injected with sculptra facial filler on the dates, 27-Nov-2019, 05-Feb-2020 and 05-Aug-2020. After the administration of the second dose of covid-19 vaccine, she developed lumpy plaques under the skin of cheeks (where sculptra was injected), which looked like marbles under skin. There were 18-20 on the right cheek and 5-6 on the left. They developed into a plaque which was 11/2 inches thick and 3-4 inches long on right cheek.  Treatment included three injections of Kenalog 10 and lidocaine, given on 12-May-2021, 16-Jun-2021 and 26-Jul-2021. Treatment also included RHA 3 filler, given on 16-Jun-2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up ADR form received included patient details, demographics, race, medical history, lab data, concomitant medications list, treatment medications, second dose of vaccine details, additional events (skin mass, skin plaque, vaccination adverse reaction, fever, chills, and myalgia), outcome.