Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Testing positive on a rapid antigen test/felt like really bad flu with fever, cough, congestion; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Testing positive on a rapid antigen test/felt like really bad flu with fever, cough, congestion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient previously received a COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to antibiotics (Allergy to Tetracycline).    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (Testing positive on a rapid antigen test/felt like really bad flu with fever, cough, congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 09-May-2022, COVID-19 (Testing positive on a rapid antigen test/felt like really bad flu with fever, cough, congestion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-May-2022, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication information was reported.  The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 16May2022.  Company Comment: This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of the mRNA-1273 vaccine. The patient experienced a 'really bad' flu with fever, cough and congestion, and tested positive for SARS-CoV-2 via a Rapid Antigen test. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 03May2022 to 07May2022. After 2 days, the patient was asymptomatic and tested negative for SARS-CoV-2 via a Rapid Antigen test. Of note, 1 week after the patient was asymptomatic, she experienced what she thought was a 'head cold' described as stuffy, runny nose. The patient again tested positive for SARS-CoV-2 via a Rapid Antigen test. However, it was reported that there was no fever and symptoms appeared to be more mild compared with the first COVID-19 infection which occurred 13 days prior. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of the mRNA-1273 vaccine. The patient experienced a 'really bad' flu with fever, cough and congestion, and tested positive for SARS-CoV-2 via a Rapid Antigen test. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 03May2022 to 07May2022. After 2 days, the patient was asymptomatic and tested negative for SARS-CoV-2 via a Rapid Antigen test. Of note, 1 week after the patient was asymptomatic, she experienced what she thought was a 'head cold' described as stuffy, runny nose. The patient again tested positive for SARS-CoV-2 via a Rapid Antigen test. However, it was reported that there was no fever and symptoms appeared to be more mild compared with the first COVID-19 infection which occurred 13 days prior. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.