Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Reinfection with COVID 11 days after completing Paxlovid; Reinfection with COVID 11 days after completing Paxlovid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Reinfection with COVID 11 days after completing Paxlovid) and DRUG INEFFECTIVE (Reinfection with COVID 11 days after completing Paxlovid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 007M20A and 025J20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Patient had no allergy.  Concurrent medical conditions included Breast cancer since 2018 and Hypertension (Mild).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 10:00 PM, the patient experienced COVID-19 (Reinfection with COVID 11 days after completing Paxlovid) and DRUG INEFFECTIVE (Reinfection with COVID 11 days after completing Paxlovid). At the time of the report, COVID-19 (Reinfection with COVID 11 days after completing Paxlovid) was resolving and DRUG INEFFECTIVE (Reinfection with COVID 11 days after completing Paxlovid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received COVID-19 vaccine previously. On 13-May-2022 at 22:00, the patient had reinfection with COVID 11 days after completing Paxlovid. No treatment drugs were reported  Company Comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history, who experienced unexpected AESI event of covid-19 infection and drug ineffective on 12-May-2022, which occurred 6 months 15 days after the 3rd dose of the mRNA-1273 (Spikevax) which was administered on 27-Oct-2021. The event occurred 11 days after patient had received 1 dose of PAXLOVID on 26-Apr-2022 which was admitted after three doses of Moderna COVID-19 Vaccine. On 13-May-2022, SARS-CoV-2 test was reported positive. The event COVID-19 infection was reported to as resolving. 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 unexpected AESI event of covid-19 infection and drug ineffective on 12-May-2022, which occurred 6 months 15 days after the 3rd dose of the mRNA-1273 (Spikevax) which was administered on 27-Oct-2021. The event occurred 11 days after patient had received 1 dose of PAXLOVID on 26-Apr-2022 which was admitted after three doses of Moderna COVID-19 Vaccine. On 13-May-2022, SARS-CoV-2 test was reported positive. The event COVID-19 infection was reported to as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.