Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: then became strongly positive again/Was almost negative on at home test then became strongly positive again.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (then became strongly positive again/Was almost negative on at home test then became strongly positive again.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C2113) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (then became strongly positive again/Was almost negative on at home test then became strongly positive again.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (then became strongly positive again/Was almost negative on at home test then became strongly positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Was almost negative on at home. On 17-May-2022, SARS-CoV-2 test: positive (Positive) strongly positive again.. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. The patient reported started feeling sick again, developed runny nose, was much more tired, slept a lot but still congested and had disrupted sleep. The patient was almost negative on at home test and then became strongly positive again. Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: No. Did you/the patient previously receive a COVID-19 Vaccine: Yes.  Company Comment: This spontaneous case concerns a 35-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred 6 months after receiving an unknown dose number of mRNA-1273 vaccine. Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid) but reported recurrence of symptom of rhinorrhea, fatigue, and excessive sleepiness. She also retested positive using a COVID-19 home antigen test. The date of initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 35-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred 6 months after receiving an unknown dose number of mRNA-1273 vaccine. Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid) but reported recurrence of symptom of rhinorrhea, fatigue, and excessive sleepiness. She also retested positive using a COVID-19 home antigen test. The date of initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.