Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Persistent positive test  recurrent symptoms starting 5/23/22/ Persistent positive test and recurrent symptoms srarting 5/23/22- fatigue cough,low grade fever; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Persistent positive test  recurrent symptoms starting 5/23/22/ Persistent positive test and recurrent symptoms srarting 5/23/22- fatigue cough,low grade fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypertension and Penicillin allergy. Concomitant products included VALSARTAN from 08-Sep-2020 to an unknown date for an unknown indication.   On 02-Apr-2022 at 10:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 22-May-2022 at 3:00 PM, the patient experienced COVID-19 (Persistent positive test  recurrent symptoms starting 5/23/22/ Persistent positive test and recurrent symptoms srarting 5/23/22- fatigue cough,low grade fever). At the time of the report, COVID-19 (Persistent positive test  recurrent symptoms starting 5/23/22/ Persistent positive test and recurrent symptoms srarting 5/23/22- fatigue cough,low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. The patient was taking other medications within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 68 year old male patient  with relevant medical history of hypertension who experienced non-serious , unexpected , ADR of Covid 19 ( Persistent positive test  recurrent symptoms starting 5/23/22),  which occurred 1 month 20 days post vaccination with the 4th dose of mRNA1273 vaccine . The information regarding the dose 1 , dose 2 and dose 3 of Covid 19 vaccine of this patient was not reported. This patient was reported to have started taking Nirmatrelvir Ritonavir ( Paxlovid, reported as a treatment drug  ) on 13th-May-2022 at an unspecified dose and frequency and noted to have persistent positive Covid 19 test with recurrent symptoms  9 days after  intake of this medication . Other details surrounding the event like other treatment medications  and other laboratories/diagnostic procedures done were not reported and  there was also no report  if any medical consultation was done. Outcome of the event  was reported as not resolved. The age of this patient and his history of hypertension ( as a Co-morbidity ) are considered as confounders for the event 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 68 year old male patient  with relevant medical history of hypertension who experienced non-serious , unexpected , ADR of Covid 19 ( Persistent positive test  recurrent symptoms starting 5/23/22),  which occurred 1 month 20 days post vaccination with the 4th dose of mRNA1273 vaccine . The information regarding the dose 1 , dose 2 and dose 3 of Covid 19 vaccine of this patient was not reported. This patient was reported to have started taking Nirmatrelvir Ritonavir ( Paxlovid, reported as a treatment drug  ) on 13th-May-2022 at an unspecified dose and frequency and noted to have persistent positive Covid 19 test with recurrent symptoms  9 days after  intake of this medication . Other details surrounding the event like other treatment medications  and other laboratories/diagnostic procedures done were not reported and  there was also no report  if any medical consultation was done. Outcome of the event  was reported as not resolved. The age of this patient and his history of hypertension ( as a Co-morbidity ) are considered as confounders for the event Covid 19. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.