Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Home test was very positive/Post nasal type mucosa/100.4 Fever/Nasal congestion/Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Home test was very positive/Post nasal type mucosa/100.4 Fever/Nasal congestion/Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.   On 24-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (Home test was very positive/Post nasal type mucosa/100.4 Fever/Nasal congestion/Headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Home test was very positive/Post nasal type mucosa/100.4 Fever/Nasal congestion/Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Body temperature: 100.4 100.4. In May 2022, SARS-CoV-2 test: positive (Positive) Very positive, negative (Negative) Negative (Day 5 post Paxlovid) and negative (Negative) Negative (Day 8 post Paxlovid).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The patient was not taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid. No concomitant medications were reported. It was reported that the patient took Paxlovid for 5 days, tested negative on day 5 and 8. The patient had postnasal type mucosa on day 8 and 9. The patient woke with 100.4 fever, nasal congestion, and headache on day 10 and home test was very positive, no waited and this was currently day 12 and still had the symptoms.  Company Comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 year 3 months after a dose mRNA-1273 vaccine (dose number not specified). It was reported that the patient took Paxlovid for 5 days, tested negative on day 5 and 8. The patient had postnasal type mucosa on day 8 and 9. She woke with 100.4 fever, nasal congestion, and headache on day 10 and home test was positive. SARS-CoV-2 test was positive as on 18-May-2022. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 year 3 months after a dose mRNA-1273 vaccine (dose number not specified). It was reported that the patient took Paxlovid for 5 days, tested negative on day 5 and 8. The patient had postnasal type mucosa on day 8 and 9. She woke with 100.4 fever, nasal congestion, and headache on day 10 and home test was positive. SARS-CoV-2 test was positive as on 18-May-2022. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.