Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: felt sick; Not necessarily adverse. I experienced Paxlovid rebound. Tested negative , antigen, on day 4/5. Symptoms improved dramatically. On day 7 I felt sick again, and then proceeded to test positive for the next 10 days. Still testing positive on day 17; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Not necessarily adverse. I experienced Paxlovid rebound. Tested negative , antigen, on day 4/5. Symptoms improved dramatically. On day 7 I felt sick again, and then proceeded to test positive for the next 10 days. Still testing positive on day 17) and MALAISE (felt sick) in a 41-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.    Concurrent medical conditions included Allergy (No product reported).   On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Not necessarily adverse. I experienced Paxlovid rebound. Tested negative , antigen, on day 4/5. Symptoms improved dramatically. On day 7 I felt sick again, and then proceeded to test positive for the next 10 days. Still testing positive on day 17). On an unknown date, the patient experienced MALAISE (felt sick). At the time of the report, COVID-19 (Not necessarily adverse. I experienced Paxlovid rebound. Tested negative , antigen, on day 4/5. Symptoms improved dramatically. On day 7 I felt sick again, and then proceeded to test positive for the next 10 days. Still testing positive on day 17) was resolving and MALAISE (felt sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient did not receive any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had not receive any treatment medication. COMPANY COMMENT: This is an spontaneous case concerning a 41-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 14-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) and MALAISE 202 days after 3rd  dose of  mRNA-1273 vaccine. On unknown day, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 41-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 14-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) and MALAISE 202 days after 3rd  dose of  mRNA-1273 vaccine. On unknown day, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.