Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041b21a and 016b21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (The patient had allergy to unknown past drug). Concomitant products included SERTRALINE and ALPRAZOLAM for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced COVID-19 (Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that symptoms returned five days after finishing the course of treatment and again tested positive for COVID.  Company comment: This spontaneous case concerns a 49-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19(Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive as on 27-May-2022. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and symptoms returned five days after finishing the course of treatment and again tested positive for COVID. 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 49-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19(Treated with Paxlovid for COVID-19/Symptoms returned five days after finishing the course of treatment and again tested positive for COVID) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive as on 27-May-2022. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and symptoms returned five days after finishing the course of treatment and again tested positive for COVID. 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.