Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Experienced new COVID symptoms / viral rebound / rapid antigen tests came back immediately positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Experienced new COVID symptoms / viral rebound / rapid antigen tests came back immediately positive) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection and Allergy (unspecified drug.).    On 19-Nov-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Experienced new COVID symptoms / viral rebound / rapid antigen tests came back immediately positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-May-2022 to 01-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Experienced new COVID symptoms / viral rebound / rapid antigen tests came back immediately positive) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) rapid antigen tests came back immediately positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug reported. It was reported patient experienced, headache, fatigue and congestion. Patient took Paxlovid for treatment of COVID-19.  Company comment  This is a spontaneous case reported by a patient, concerning a 42 year old male patient, with no relevant medical history reported, who experienced the non serious, unexpected AESI of COVID-19, which occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that the patient experienced headache, fatigue and congestion. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID) from 27-May-2022 to 01-Jun-2022 for COVID-19 treatment. On an unknown date, SARS-CoV-2 test was done and the rapid antigen tests came back immediately positive. The event had not resolved. Patient had concurrent illness with HIV Infection which is a risk factor. Ongoing Covid 19 pandemia is a confounder. No concomitant and treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a spontaneous case reported by a patient, concerning a 42 year old male patient, with no relevant medical history reported, who experienced the non serious, unexpected AESI of COVID-19, which occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that the patient experienced, headache, fatigue and congestion. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID) from 27-May-2022 to 01-Jun-2022 for COVID-19 treatment. On an unknown date, SARS-CoV-2 test was done and the rapid antigen tests came back immediately positive. The event had not resolved. Patient had concurrent illness with HIV Infection which is a risk factor. Ongoing Covid 19 pandemia is a confounder. No concomitant and treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.