Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive home antigen test 4/28/ Tested positive again 5/14 with sore throat and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive home antigen test 4/28/ Tested positive again 5/14 with sore throat and fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (unknown drug).    On 21-Apr-2022 at 2:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (Positive home antigen test 4/28/ Tested positive again 5/14 with sore throat and fatigue). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 03-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive home antigen test 4/28/ Tested positive again 5/14 with sore throat and fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was reported.  The patient was not taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient was tested Positive in home antigen test on 28-Apr-2022 with cold symptoms and Paxlovid was completed in 5 days on 29-Apr-2022 and symptoms disappear on 03-May-2022 and antigen test negative on 09-May-2022. Health and energy totally normal for 5 days. But then again tested positive 14-May-2022 with sore throat and fatigue. The device date 14-May-2022.  Company Comment: This is a spontaneous case concerning a 71-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19. The patient tested positive for COVID home antigen test with cold symptoms 7 days after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and symptoms disappeared. The antigen test was negative after 11 days from the date the patient tested positive. After 16 days from the date of the positive test, the patient had sore throat with fatigue and reported to have positive test again. The outcome of the event was unknown at the time of the report. It should be noted that the dose was reported as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19. The patient tested positive for COVID home antigen test with cold symptoms 7 days after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and symptoms disappeared. The antigen test was negative after 11 days from the date the patient tested positive. After 16 days from the date of the positive test, the patient had sore throat with fatigue and reported to have positive test again. The outcome of the event was unknown at the time of the report. It should be noted that the dose was reported as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.