Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     PTSD (Post traumatic stress disorder).  The patient's past medical history included Systemic lupus erythematosis and Fibromyalgia. Concurrent medical conditions included Steroid diabetes (Steroid induced DM), Hypertension, Migraine, Attention deficit disorder, Insomnia, Neuropathy, Penicillin allergy and Drug allergy. Concomitant products included PREGABALIN (LYRICA), METHOTREXATE, TRAMADOL, IBUPROFEN, ESZOPICLONE (LUNESTA), CEFIXIME (FLEXERIL [CEFIXIME]), TOPIRAMATE, METOPROLOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and RITUXIMAB (RITUXAN) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient don't feel up to getting up and getting it out. She had rebound of Covid symptoms about 3-4 days after getting better. The symptoms were much worse and she test positive again within 3 minutes.   Patient took other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a 36-year-old female patient, with relevant medical history of Systemic Lupus Erythematosus, steroid induced Diabetes Mellitus, and Hypertension, who experienced the unexpected non-serious AESI of COVID-19 that occurred on an unknown time after receiving mRNA-1273 vaccine as 4th dose on an unknown date. Patient took Paxlovid for 5 days as a treatment regimen. Patient reported rebound of COVID symptoms 3-4 days after getting better, and symptoms were much worse and tested positive again.  Clinical course and treatment details were not reported. The multiple co-morbid conditions of the patient could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was assessed as non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient, with relevant medical history of Systemic Lupus Erythematosus, steroid induced Diabetes Mellitus, and Hypertension, who experienced the unexpected non-serious AESI of COVID-19 that occurred on an unknown time after receiving mRNA-1273 vaccine as 4th dose on an unknown date. Patient took Paxlovid for 5 days as a treatment regimen. Patient reported rebound of COVID symptoms 3-4 days after getting better, and symptoms were much worse and tested positive again.  Clinical course and treatment details were not reported. The multiple co-morbid conditions of the patient could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was assessed as non-serious based on medical judgement.