Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I first tested positive on May 13. Took Paxlovid from 5/14-18. On 5/23 began suffering a relapse and continue to test positive as of the current moment.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (I first tested positive on May 13. Took Paxlovid from 5/14-18. On 5/23 began suffering a relapse and continue to test positive as of the current moment.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066k21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypothyroidism (Low thyroid) and Drug allergy. Concomitant products included PROGESTERONE, LEVOTHYROXINE, TESTOSTERONE and ESTRADIOL (ESTROGEN) for an unknown indication.   On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 23-May-2022, the patient experienced COVID-19 (I first tested positive on May 13. Took Paxlovid from 5/14-18. On 5/23 began suffering a relapse and continue to test positive as of the current moment.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for Adverse event, at a dose of second course and INDOMETACIN SODIUM (INDOCIN [INDOMETACIN SODIUM]) for Adverse event, at a dose of 3 day course. At the time of the report, COVID-19 (I first tested positive on May 13. Took Paxlovid from 5/14-18. On 5/23 began suffering a relapse and continue to test positive as of the current moment.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) first tested positive. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Patient's symptoms included fatigue, congestion, copious clear nasal discharge and diarrhea.  Device Date was reported 26-May-2022.  Company Comment:  This is a spontaneous case concerning  a  64-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The event occurred 31 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test, twice (May 13, 2022 and May 23, 2022). Patient was treated with nirmatrelvir, ritonavir tablet at an unspecified dose and Indometacin at a dose of 3 day course. It was noted patient on May 23, 2022 begin suffering relapse. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a  64-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The event occurred 31 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test, twice (May 13, 2022 and May 23, 2022). Patient was treated with nirmatrelvir, ritonavir tablet at an unspecified dose and Indometacin at a dose of 3 day course. It was noted patient on May 23, 2022 begin suffering relapse. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.