Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Angioedema, Contusion, Device breakage
Clinical narrative: The lips would present as an angioedema type of response.; her breast implant-left-silicone gel-is has ruptured as well; swelling like this has continued on, where she would have bouts of swelling lasting hours up to 3 days/The bouts of swelling would occur approximately 2-3 weeks apart; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (The lips would present as an angioedema type of response.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product POLY-L-LACTIC ACID (SCULPTRA) for an unknown indication.    No relevant history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient started POLY-L-LACTIC ACID (SCULPTRA) (unknown route) 9 milliliter. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced CONTUSION (swelling like this has continued on, where she would have bouts of swelling lasting hours up to 3 days/The bouts of swelling would occur approximately 2-3 weeks apart). On an unknown date, the patient experienced ANGIOEDEMA (The lips would present as an angioedema type of response.) (seriousness criterion medically significant) and DEVICE BREAKAGE (her breast implant-left-silicone gel-is has ruptured as well). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; EPINEPHRINE at an unspecified dose and frequency and Surgery (breast implant) for Device breakage. In October 2021, CONTUSION (swelling like this has continued on, where she would have bouts of swelling lasting hours up to 3 days/The bouts of swelling would occur approximately 2-3 weeks apart) had resolved. At the time of the report, ANGIOEDEMA (The lips would present as an angioedema type of response.) and DEVICE BREAKAGE (her breast implant-left-silicone gel-is has ruptured as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: Did allergy testing for food and nothing came back on her results..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Three days after the 1st vaccine received, the patient started to experience facial swelling across lower 2/3rds of face 3. This swelling lasted less than 1 day. She reported swelling like this had continued, where she would have bouts of swelling lasting hours up to 3 days, this pattern continued till October 2021. The bouts of swelling would occur approximately 2-3 weeks apart. In the Emergency Room, they gave her a prescription of Claritin and an EPI pen for future use. They did allergy testing for food and nothing came back on her results. The lips would present as an angioedema type of response. She denied during this experiences that it caused her any pain. Denied any open sores occurred. Denied taking any prescription medications, only OTC vitamins. Reported that the left was more reactive than the right. She reported sleeping on her back and not on her sides. No known autoimmune disorders. Never had chemo/radiation. Denied any other illnesses (UTI, pneumonia, etc) No dental work at that time. Coincidentally she reported her breast implant-left-silicone gel-is had ruptured as well.  Reporter stated that they did not treat her for anything and felt the swelling of her lips and lower two-thirds of her face aren't related to Sculptra use.They just learnt about this. Patient informed them on 28-FEB-2022 when she came in for her Dysport injection.   Nurse provides previous Dysport injection product details: LOT NUMBER:U050003 EXP:31-JAN-2022 Injected on 11-JUN-2021 Swelling was reported in May 2021.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.