Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, SARS-CoV-2 test, Swelling face
Clinical narrative: facial swelling/pain on the left side of her face/pain and swelling; major allergic reaction to both Botox and fillers/critical mass/ It continue to swelled but it got much worse; COVID-19/not feeling well; Drug ineffective; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (facial swelling/pain on the left side of her face/pain and swelling), COVID-19 (COVID-19/not feeling well), DRUG INEFFECTIVE (Drug ineffective) and HYPERSENSITIVITY (major allergic reaction to both Botox and fillers/critical mass/ It continue to swelled but it got much worse) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032f21a, 039a21a and 031a21a) for COVID-19 prophylaxis.    Co-suspect product included non-company product BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    The patient's past medical history included Dermal filler reaction (corners of her mouth where she had fillers years ago).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started BOTULINUM TOXIN TYPE A (BOTOX) (unknown route) at an unspecified dose. On 06-May-2022, the patient experienced COVID-19 (COVID-19/not feeling well) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced SWELLING FACE (facial swelling/pain on the left side of her face/pain and swelling) and HYPERSENSITIVITY (major allergic reaction to both Botox and fillers/critical mass/ It continue to swelled but it got much worse). At the time of the report, SWELLING FACE (facial swelling/pain on the left side of her face/pain and swelling) had not resolved and COVID-19 (COVID-19/not feeling well), DRUG INEFFECTIVE (Drug ineffective) and HYPERSENSITIVITY (major allergic reaction to both Botox and fillers/critical mass/ It continue to swelled but it got much worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. Patient Co-Suspect drug included derma filler injection.  Patient had a medical attention where patient received steroid shots directly into the swelling site around filler in face for approximately twice a week for two months. Patient still have steroids and symptoms (swelling face, facial pain) has been improved but patient still had pain with swelling for derma filler and derma filler was putted in patient cheeks. Following vaccination patient started to experience symptoms with no pain on early Feb-2022. Patient symptoms (swelling face, facial pain) continued when patient received derma filler on 08-Mar-2022 and symptoms got worse, all-over face of patient. Patient had symptoms (Swelling face, Facial pain) in corners mouth where patient had fillers years ago.  Patient treatment medication included steroid. Patient did not have allergies history for medications, food, and other products. Patient did not have any acute and Chronic illnesses at the time of vaccination. Patient did not have any other vaccines given within one month prior to Moderna COVID-19 vaccine  Company Comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-Cov test) 6 months and 6 days after vaccination with a third dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 28 days, hence drug ineffective was also noted. 3 months prior to being diagnosed with Covid-19, the patient experienced symptoms "with no pain", facial swelling, and pain on the left side of her face. The symptoms persisted and became worse after she got a dermal filler approximately a month after. The patient was then diagnosed with Covid-19 after 2 months. 1 month and 8 days after getting Covid-19, the swelling in her face became a mass and was accompanied with pain. The patient also received steroids shots into the swelling around the filler in her face. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-Cov test) 6 months and 6 days after vaccination with a third dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 28 days, hence drug ineffective was also noted. 3 months prior to being diagnosed with Covid-19, the patient experienced symptoms "with no pain", facial swelling, and pain on the left side of her face. The symptoms persisted and became worse after she got a dermal filler approximately a month after. The patient was then diagnosed with Covid-19 after 2 months. 1 month and 8 days after getting Covid-19, the swelling in her face became a mass and was accompanied with pain. The patient also received steroids shots into the swelling around the filler in her face. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.