Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive with a rapid antigen test on 4/30/22. Tested negative with antigen on 5/8 and 5/9 and negative with PCR on 5/10. Tested positive on a rapid antigen on 5/17/22.; I tested positive with a rapid antigen test on 4/30/22.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive with a rapid antigen test on 4/30/22.) and COVID-19 (I tested positive with a rapid antigen test on 4/30/22. Tested negative with antigen on 5/8 and 5/9 and negative with PCR on 5/10. Tested positive on a rapid antigen on 5/17/22.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID] and CETIRIZINE for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 30-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I tested positive with a rapid antigen test on 4/30/22.). On 17-May-2022, the patient experienced COVID-19 (I tested positive with a rapid antigen test on 4/30/22. Tested negative with antigen on 5/8 and 5/9 and negative with PCR on 5/10. Tested positive on a rapid antigen on 5/17/22.). At the time of the report, COVID-19 (I tested positive with a rapid antigen test on 4/30/22.) had resolved and COVID-19 (I tested positive with a rapid antigen test on 4/30/22. Tested negative with antigen on 5/8 and 5/9 and negative with PCR on 5/10. Tested positive on a rapid antigen on 5/17/22.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2022, SARS-CoV-2 test: positive (Positive) Tested positive with a rapid antigen test. On 08-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative with antigen. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative with antigen. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative with PCR. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive on a rapid antigen.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.  Company Comment: This spontaneous case concerns a 55-year-old female patient, with no relevant medical history, who experienced the unexpected AESI of COVID-19 on two occasions. The events occurred approximately 5 months and 19 days, and 6 months and 6 days, after receiving the third dose of mRNA-1273 Vaccine. The patient tested positive twice in SARS-CoV-2 antigen test and negative on one SARS-CoV-2 PCR test. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with no relevant medical history, who experienced the unexpected AESI of COVID-19 on two occasions. The events occurred approximately 5 months and 19 days, and 6 months and 6 days, after receiving the third dose of mRNA-1273 Vaccine. The patient tested positive twice in SARS-CoV-2 antigen test and negative on one SARS-CoV-2 PCR test. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.