Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid again on BD anitgen test on 25-May-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for covid again on BD anitgen test on 25-May-2022.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AFib, Hypertension, Hyperlipidemia and Drug allergy (No drugs were reported.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for covid again on BD anitgen test on 25-May-2022.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid again on BD anitgen test on 25-May-2022.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-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 any other medications/products within 2 weeks of starting COVID-19 treatment.   The patient did receive a COVID-19 vaccine.  Reporter reported that Patient was infected with covid on 11-May-2022 and started Paxlovid on 13-May-2022.  Resolution of symptoms (rhinorrhea) on 18-May-2022 and had a negative antigen test. Then recurrence of symptoms (rhinorrhea) on 22-May-2022. Tested positive for covid on anitgen test on 25-May-2022.  Concomitant drugs were not reported.   Company comment:  This is a spontaneous case concerning a 71-year-old, male patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 33 days after the fourth dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient experienced Covid-19 approximately 33 days after the fourth dose of mRNA-1273 vaccine administration. Approximately 2 days after, patient took Nirmatrelvir + Ritonavir (Paxlovid). 1 day after the last dose of Paxlovid, patient symptom of rhinorrhea had resolved with negative antigen test. Approximately 5 days after the last dose of Paxlovid, recurrence of symptom of rhinorrhea reoccurred. Approximately 8 days after the last dose of Paxlovid, patient was tested positive on antigen test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old, male patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 33 days after the fourth dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient experienced Covid-19 approximately 33 days after the fourth dose of mRNA-1273 vaccine administration. Approximately 2 days after, patient took Nirmatrelvir + Ritonavir (Paxlovid). 1 day after the last dose of Paxlovid, patient symptom of rhinorrhea had resolved with negative antigen test. Approximately 5 days after the last dose of Paxlovid, recurrence of symptom of rhinorrhea reoccurred. Approximately 8 days after the last dose of Paxlovid, patient was tested positive on antigen test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.