Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Began Paxlovid 4 days from onset of symptoms (May 10) and 3 days from a positive rapid antigen test (May 11).; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Began Paxlovid 4 days from onset of symptoms (May 10) and 3 days from a positive rapid antigen test (May 11).) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Blood pressure and Drug allergy (Unknown drug.). Concomitant products included LISINOPRIL (LISINOPRIL LUPIN) from 01-Jan-2022 to an unknown date and ESTRADIOL from 08-Apr-2022 to an unknown date for an unknown indication.    On 19-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced COVID-19 (Began Paxlovid 4 days from onset of symptoms (May 10) and 3 days from a positive rapid antigen test (May 11).). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Began Paxlovid 4 days from onset of symptoms (May 10) and 3 days from a positive rapid antigen test (May 11).) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Began Paxlovid 4 days from onset of symptoms (May 10) and 3 days from a positive rapid antigen test (May 11). Continued treatment for full 5 days. Symptoms improved and were entirely gone after 7 days. Tested negative on May 20 on rapid antigen test. On May 23 sore throat and congestion began. Took a rapid antigen test that was negative but symptoms continued. Slight fever on May 25 so took another rapid test that was positive. Still positive on rapid test on May 27. Company comment: This spontaneous case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 172 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen of Paxlovid on May 13-18, 2022, to which two SARS-CoV-2 tests were done on May 20 and 23, 2022 which revealed a negative result, patient experienced sore throat and congestion with fever, on May 27, 2022, a SARS-CoV-2 test was again done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 172 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen of Paxlovid on May 13-18, 2022, to which two SARS-CoV-2 tests were done on May 20 and 23, 2022 which revealed a negative result, patient experienced sore throat and congestion with fever, on May 27, 2022, a SARS-CoV-2 test was again done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.