Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Lot of petechiae in her vessels on periphery of marionette line; Persistent warmth in her NLF since injection; It didn't feel normal; A month after the injections she developed nodules; Discoloration of the skin just sort of pink and purple in the area of injections; Swelling in areas of injection sites which has persisted; Persistent redness in her NLF since injection/ Had redness in areas of injection sites; Felt stinging and burning; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (Lot of petechiae in her vessels on periphery of marionette line), INJECTION SITE WARMTH (Persistent warmth in her NLF since injection), FEELING ABNORMAL (It didn't feel normal), INJECTION SITE NODULE (A month after the injections she developed nodules) and INJECTION SITE DISCOLOURATION (Discoloration of the skin just sort of pink and purple in the area of injections) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication and HYALURONIC ACID (RESTYLANE) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) 1 dosage form and HYALURONIC ACID (RESTYLANE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PETECHIAE (Lot of petechiae in her vessels on periphery of marionette line), INJECTION SITE WARMTH (Persistent warmth in her NLF since injection), FEELING ABNORMAL (It didn't feel normal), INJECTION SITE NODULE (A month after the injections she developed nodules), INJECTION SITE DISCOLOURATION (Discoloration of the skin just sort of pink and purple in the area of injections), INJECTION SITE SWELLING (Swelling in areas of injection sites which has persisted), INJECTION SITE ERYTHEMA (Persistent redness in her NLF since injection/ Had redness in areas of injection sites) and INJECTION SITE PAIN (Felt stinging and burning). At the time of the report, PETECHIAE (Lot of petechiae in her vessels on periphery of marionette line), FEELING ABNORMAL (It didn't feel normal), INJECTION SITE NODULE (A month after the injections she developed nodules), INJECTION SITE DISCOLOURATION (Discoloration of the skin just sort of pink and purple in the area of injections) and INJECTION SITE PAIN (Felt stinging and burning) outcome was unknown and INJECTION SITE WARMTH (Persistent warmth in her NLF since injection), INJECTION SITE SWELLING (Swelling in areas of injection sites which has persisted) and INJECTION SITE ERYTHEMA (Persistent redness in her NLF since injection/ Had redness in areas of injection sites) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she received Restylane Defyne in the nasolabial folds and marionette lines bilaterally and Restylane Kysse in the lips.   Concomitant medications were not provided. Treatment information includes: On 19-Feb-2022 patient had an injection of Depo Medrol 80mg and on 22-Feb-2022 patient went back to the injector where they dissolved some of it and treated with Candela, an intensive pulse light therapy device for discoloration and petechia.  Company Comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, non-serious, AESI event of Petechiae approximately 6 weeks after the third dose of mRNA-1273. Patient received the facial filler injections (Hyaluronic acid + Lidocaine) in nasolabial folds and lips 2 weeks after receiving the booster vaccine. Within 24 hours, patient developed Injection site erythema, warmth, stinging and burning, swelling and it felt abnormal. After 1 month, Injection site nodules, petechiae and skin discoloration developed which was treated with intensive pulse light therapy. Administration of facial filler injections (Hyaluronic acid + Lidocaine) is the strong confounding factor. At the time of report, outcome of the events was Unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, non-serious, AESI event of Petechiae approximately 6 weeks after the third dose of mRNA-1273. Patient received the facial filler injections (Hyaluronic acid + Lidocaine) in nasolabial folds and lips 2 weeks after receiving the booster vaccine. Within 24 hours, patient developed Injection site erythema, warmth, stinging and burning, swelling and it felt abnormal. After 1 month, Injection site nodules, petechiae and skin discoloration developed which was treated with intensive pulse light therapy. Administration of facial filler injections (Hyaluronic acid + Lidocaine) is the strong confounding factor. At the time of report, outcome of the events was Unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.