Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/COVID rebound. Tested positive and became; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19/COVID rebound. Tested positive and became) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had unspecified allergy.  Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.    On 12-Jan-2022 at 5:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/COVID rebound. Tested positive and became). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/COVID rebound. Tested positive and became) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was on Paxlovid for the Treatment of COVID-19 from 02-May-2022 to 07-May-2022. The patient received COVID-19 vaccine previously. Device Date reported as 16-May-2022  Company Comment: This is a spontaneous case concerning a 43-year-old male patient with a medical history of Psoriatic arthritis and concomitant medication with Enbrel, who experienced the unexpected non-serious AESI COVID-19 which occurred approximately 4 months after receiving a dose of mRNA-1273 Vaccine, dose 4 in vaccine series. 3 months 20 days after vaccination, patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid). However, 7 days after finishing the 5-day course of Paxlovid, he tested positive and became symptomatic again after testing negative on unspecified date. The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19, and date of the initial COVID-19 test were not provided in this report. There was also no information regarding the first three doses of COVID-19 vaccination. The patient's medical history of Psoriatic arthritis, which increases the risk for COVID-19, and concomitant medication with Enbrel, which is an immunosuppressant, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 43-year-old male patient with a medical history of Psoriatic arthritis and concomitant medication with Enbrel, who experienced the unexpected non-serious AESI COVID-19 which occurred approximately 4 months after receiving a dose of mRNA-1273 Vaccine, dose 4 in vaccine series. 3 months 20 days after vaccination, patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid). However, 7 days after finishing the 5-day course of Paxlovid, he tested positive and became symptomatic again after testing negative on unspecified date. The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19, and date of the initial COVID-19 test were not provided in this report.There was also no information regarding the first three doses of COVID-19 vaccination. The patient's medical history of Psoriatic arthritis, which increases the risk for COVID-19, and concomitant medication with Enbrel, which is an immunosuppressant, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.