Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 013M20A and 027L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Allergic reaction was reported for an unspecified drug.    On 22-Jan-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021 at 10:30 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021 at 3:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: negative (Negative) tested negative 8 days after finishing. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive again 11 days after finishing treatment.. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant mediaction was reported. It was reported that patient finished course of treatment of Paxlovid and tested negative 8 days after finishing. Tested positive again 11 days after finishing treatment. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 29-May-2022.  Company Comment: This spontaneous  case concerns a 63 year old  female patient with no relevant medical history reported, who experienced Non-serious , unexpected, AESI of Covid 19 which occurred on an unknown date  post vaccination with the third dose of mRNA-1273 vaccine . The dose 1 and dose 2 of the Covid 19 vaccine of this patient were  also a mRNA-1273 vaccine given on 24-02-2021 and 2201-2021. This patient was treated with , non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment at an unspecified dose and frequency given for 5 days  from May 12-16, 2022  and  reported to have completed the full course. This patient tested  negative 8 days after the treatment however 11 days after finishing the treatment a SARS-COV 2 test was done  yielding positive results. The details surrounding the event were not reported including other treatment details, results of other laboratories/diagnostic procedures . There are no reports if any medical consult was done. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report; Sender's Comments: This spontaneous  case concerns a 63 year old  female patient with no relevant medical history reported, who experienced Non-serious , unexpected, AESI of Covid 19 which occurred on an unknown date  post vaccination with the third dose of mRNA-1273 vaccine . The dose 1 and dose 2 of the Covid 19 vaccine of this patient were  also a mRNA-1273 vaccine given on 24-02-2021 and 2201-2021. This patient was treated with , non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment at an unspecified dose and frequency given for 5 days  from May 12--16, 2022  and  reported to have completed the full course. This patient tested  negative 8 days after the treatment however 11 days after finishing the treatment a SARS-COV 2 test was done  yielding positive results. The details surrounding the event were not reported including other treatment details, results of other laboratories/diagnostic procedures . There are no reports if any medical consult was done. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.