Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; Rebound case of Covid 7 days after completing the 5 day course of Paxlovid/symptoms resumed and test was positive again.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and COVID-19 (Rebound case of Covid 7 days after completing the 5 day course of Paxlovid/symptoms resumed and test was positive again.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Blood pressure high and Allergy. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from May 2010 to an unknown date and HYDROCHLOROTHIAZIDE from 13-Aug-2021 to an unknown date for an unknown indication.   On 22-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022 at 8:00 AM, the patient experienced COVID-19 (Rebound case of Covid 7 days after completing the 5 day course of Paxlovid/symptoms resumed and test was positive again.). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved. At the time of the report, COVID-19 (Rebound case of Covid 7 days after completing the 5 day course of Paxlovid/symptoms resumed and test was positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient experienced rebound case of Covid 7 days after completing the 5 day course of Paxlovid. The symptoms had resolved, and home test was negative, symptoms resumed, and test was positive again.  The device date was reported as 26-May-2022.  Company comment: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 approximately 5 months after last dose of mRNA-1273 (Spikevax) vaccine. The patient had received three doses of mRNA-1273 (Spikevax) last being on 23-Dec-2021. It was reported that Covid symptoms re-occurred 7 days after the patient completed a 5-day course of Paxlovid on 18-May-2022. On 25-May-2022, SARS-CoV-2 test reported as positive. It was reported that the symptoms of first episode of Covid had resolved and home test was negative, then symptoms resumed, and test was positive again. Outcome of the event was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 approximately 5 months after last dose of mRNA-1273 (Spikevax) vaccine. The patient had received three doses of mRNA-1273 (Spikevax) last being on 23-Dec-2021. It was reported that Covid symptoms re-occurred 7 days after the patient completed a 5-day course of Paxlovid on 18-May-2022. On 25-May-2022, SARS-CoV-2 test reported as positive. It was reported that the symptoms of first episode of Covid had resolved and home test was negative, then symptoms resumed, and test was positive again. Outcome of the event was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.