Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Drug allergy (unknown drug history.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received 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 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient did receive a COVID-19 Vaccine previously.  Company comment: This spontaneous case concerns a 63-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 6 months after the administration of a dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 15-May to 20-May. Patient tested negative on day 7 and 10 after taking Paxlovid. Patient again tested positive on day 14. Patient received 2 more doses of mRNA-1273 vaccine prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 6 months after the administration of a dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 15-May to 20-May. Patient tested negative on day 7 and 10 after taking Paxlovid. Patient again tested positive on day 14. Patient received 2 more doses of mRNA-1273 vaccine prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.