Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Took Paxlovid on Days 2-6 of a Covid infection that started on 05May2022/Tested negative on Day 9/Symptoms returned and tested positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Took Paxlovid on Days 2-6 of a Covid infection that started on 05May2022/Tested negative on Day 9/Symptoms returned and tested positive.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 028L20A and 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Blood pressure high (HBP) and Allergy NOS. Concomitant products included MELOXICAM from 01-Jan-2022 to 24-May-2022, ATENOLOL from 01-Jan-2022 to 24-May-2022, LOSARTAN from 01-Jan-2022 to 24-May-2022, AMLODIPINE from 01-Jan-2022 to 24-May-2022, ROSUVASTATIN from 01-Jan-2022 to 24-May-2022, LEVOCETIRIZINE from 01-Jan-2022 to 24-May-2022, FAMOTIDINE from 01-Jan-2022 to 24-May-2022, CALCIUM from 01-Jan-2022 to 24-May-2022, BIOTIN from 01-Jan-2022 to 24-May-2022, CURCUMA LONGA, PIPER NIGRUM (NATURES BOUNTY TUMERIC) from 01-Jan-2022 to 24-May-2022 and AZELASTINE from 01-Jan-2022 to 24-May-2022 for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Took Paxlovid on Days 2-6 of a Covid infection that started on 05May2022/Tested negative on Day 9/Symptoms returned and tested positive.). At the time of the report, COVID-19 (Took Paxlovid on Days 2-6 of a Covid infection that started on 05May2022/Tested negative on Day 9/Symptoms returned and tested positive.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: negative (Negative) Tested negative on  Day 9. and positive (Positive) tested positive on  Day 14..         Patient took Paxlovid on Days 2-6 of a Covid infection that started on 05May2022. Tested negative on Day 9. Symptoms returned and tested positive on Day 14.  Treatment details was not reported.  The device date was reported as 24-May-2022. Company comment: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 232 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given 7 months prior, the interval between the two doses is 30 days. The patient started Paxlovid treatment regimen for 2-6 days, the patient tested negative on SARS-CoV-2 test on day 9 however, 5 days after, the symptoms recurred, and the patient was tested positive on SARS-CoV-2 test. 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 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 232 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given 7 months prior, the interval between the two doses is 30 days. The patient started Paxlovid treatment regimen for 2-6 days, the patient tested negative on SARS-CoV-2 test on day 9 however, 5 days after, the symptoms recurred, and the patient was tested positive on SARS-CoV-2 test. 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.