Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of drug was not reported).    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Rapid covid home test. In 2022, SARS-CoV-2 test: negative (Negative) Turned negative On Paxlovid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Company comment: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) which occurred approximately 6 months after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022   for COVID-19 treatment SARS-CoV-2 test was positive as on May 2022 however negative turned negative after  Paxlovid.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) which occurred approximately 6 months after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022   for COVID-19 treatment SARS-CoV-2 test was positive as on May 2022 however negative turned negative after  Paxlovid.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.