Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive twice using the Covid home test kits; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive twice using the Covid home test kits) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Cardiovascular disorder. Concurrent medical conditions included Type 2 diabetes mellitus and Allergic reaction to drug (name of drug is not reported).   On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 11-May-2022, the patient experienced COVID-19 (tested positive twice using the Covid home test kits). At the time of the report, COVID-19 (tested positive twice using the Covid home test kits) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive twice. On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for 4 consecutive days.         No concomitant medication were provided  Patient tested negative for 4 consecutive days with  COVID home test kits. Patient had very slight symptoms at night and early morning a bit of mucus and slight cough.  No Treatment medication were provided  Company comment- This spontaneous case concerns a 63-year-old male patient with relevant medical history of Type 2 Diabetes and Cardiovascular disease, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 3 weeks after receiving a fourth dose of mRNA-1273 Vaccine.  After completing the Paxlovid regimen, the patient tested negative for 4 consecutive days with Covid home test kits. Since then, he has tested positive twice using the Covid home test kits.  He had very slight symptoms, at night or early morning, with a bit of mucous and slight cough. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old male patient with relevant medical history of Type 2 Diabetes and Cardiovascular disease, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 3 weeks after receiving a fourth dose of mRNA-1273 Vaccine.  After completing the Paxlovid regimen, the patient tested negative for 4 consecutive days with Covid home test kits. Since then, he has tested positive twice using the Covid home test kits.  He had very slight symptoms, at night or early morning, with a bit of mucous and slight cough. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.