Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on 13Aug2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 on 13Aug2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes since 2000. Concomitant products included METFORMIN from 2000 to an unknown date for Diabetes.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced COVID-19 (Patient tested positive for COVID-19 on 13Aug2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 15-Aug-2022 to 19-Aug-2022 for COVID-19, at a dose of white and pink pills in the morning and in the evening. At the time of the report, COVID-19 (Patient tested positive for COVID-19 on 13Aug2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 21-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 23-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 25-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 05-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         Patient ethnicity was reported. It was reported that after testing positive for COVID-19 on 13Aug2022, patient spoke to an emergency doctor who prescribed the patient a 5 day treatment of Paxlovid. Patient had been testing positive for COVID-19 every 2days since testing COVID-19 positive on 13Aug2022. on the day of reporting patient had not tested because patient doesn't trust the test anymore. It was further reported that the patient was totally without symptoms and only had tested because patient's husband had a cough. Company Comment: This spontaneous  case concerns a 78 year old female patient with relevant medical history of Diabetes , who experienced Non-serious , unexpected , AESI of Covid 19 . Onset latency of  the event cannot be assessed since the date of vaccination with the mRNA-1273 vaccine was not reported. This patient received 4 doses of mRNA-1273 vaccine . This patient initially tested positive for SARS-COV 2 test done last 13 Aug 2022 . She  was treated with NIRMATRELVIR, RITONAVIR ( Paxlovid ) for 5 days as she spoke with  a ER physician ,  however upon repeat testing she remained positive for SARS-COV 2 test on Aug 21, .23. 25 and Sept 5, 2022.  She denied any symptoms  but just tested since her husband had cough. Outcome of the event was not resolved. The age of this patient and her current medical condition of Diabetes are considered as confounders for the event Covid 19 ( her age and Diabetes condition may affect the immune response of the patient that may make her prone to infection including Covid 19 ) . 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 78 year old female patient with relevant medical history of Diabetes , who experienced Non-serious , unexpected , AESI of Covid 19 . Onset latency of  the event cannot be assessed since the date of vaccination with the mRNA-1273 vaccine was not reported. This patient received 4 doses of mRNA-1273 vaccine . This patient initially tested positive for SARS-COV 2 test done last 13 Aug 2022 . She  was treated with NIRMATRELVIR, RITONAVIR ( Paxlovid ) for 5 days as she spoke with  a ER physician ,  however upon repeat testing she remained positive for SARS-COV 2 test on Aug 21, .23. 25 and Sept 5, 2022.  She denied any symptoms  but just tested since her husband had cough. Outcome of the event was not resolved. The age of this patient and her current medical condition of Diabetes are considered as confounders for the event Covid 19 ( her age and Diabetes condition may affect the immune response of the patient that may make her prone to infection including Covid 19 ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.