Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Furuncle, Nausea, Necrotising fasciitis, Pyrexia
Clinical narrative: Had an emergency surgery at the hospital due to a necrotizing fasciitis; Boiling not on the injection site; Fever; Been fuzzy; Started to feel nauseated for a few days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis), FURUNCLE (Boiling not on the injection site), PYREXIA (Fever), NAUSEA (Started to feel nauseated for a few days) and FEELING ABNORMAL (Been fuzzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes, ESCITALOPRAM OXALATE (LEXAPRO) and ATORVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NAUSEA (Started to feel nauseated for a few days). On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis) (seriousness criteria hospitalization, medically significant and intervention required). On an unknown date, the patient experienced FURUNCLE (Boiling not on the injection site), PYREXIA (Fever) and FEELING ABNORMAL (Been fuzzy). The patient was hospitalized on 15-Apr-2021 due to NECROTISING FASCIITIS. The patient was treated with Surgery for Necrotising fasciitis. At the time of the report, NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis) and FEELING ABNORMAL (Been fuzzy) had not resolved, FURUNCLE (Boiling not on the injection site) and PYREXIA (Fever) outcome was unknown and NAUSEA (Started to feel nauseated for a few days) had resolved.            Concomitant products also included allergy medicines.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  On 08 Mar 2021, patient received first dose of Moderna COVID-19 Vaccine. On 05 Apr 2021, patient received second dose of Moderna COVID-19 Vaccine on either right or both arms as she couldn't remember. Patient reported that four days after receiving the second dose of vaccine, she felt nauseated for a few days and then started with a fever and a boiling, not on the injection site. On 15 Apr 2021, the patient had an emergency surgery at the hospital due to a necrotizing fasciitis.  The patient said they needed to cut it out immediately because it was a flesh eating bacteria in the groin area. The patient mentioned that has been fuzzy and couldn't remember its friend's name when asked for a possible AE it mentioned. The patient had diabetes but that was doing well and was completely healthy.  Treatment information included doxycycline (doxi something), multiple kind of antibiotics and fentomicine.  The patient mentioned it (the wound) has to heal from inside out.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient´s medical history of diabetes mellitus could be a contributory risk factor for the necrotizing fasciitis