Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Home antigen test was strong positive/Developed fatigue and congestion; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Seqirus Quadrivalent Influenza Vaccine (Seqirus Quadrivalent Influenza Vaccine 2016-2017) from 2016 to 2017. Past adverse reactions to the above products included Allergy with Seqirus Quadrivalent Influenza Vaccine. Concurrent medical conditions included Hypertension.    On 03-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022 at 5:00 PM, the patient experienced COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Strong positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment with Paxlovid. It was further reported that today, on 18-May-2022, four days after completing the course of Paxlovid, the patient had developed fatigue, congestion and at the patient home antigen test was strong positive. No treatment medications were reported.  Company comment- This spontaneous case concerns a 43-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred 6 months and 15 days after vaccination with a third dose of mRNA-1273. The patient experienced Covid-10 and took Paxlovid. 4 days after completing his course of Paxlovid, the patient developed fatigue and congestion. The home antigen test done was positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred 6 months and 15 days after vaccination with a third dose of mRNA-1273. The patient experienced Covid-10 and took Paxlovid. 4 days after completing his course of Paxlovid, the patient developed fatigue and congestion. The home antigen test done was positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.