Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebounded with a positive COVID rapid test on 5/16 following numerous negative rapid tests; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Rebounded with a positive COVID rapid test on 5/16 following numerous negative rapid tests) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma and Constipation. Concomitant products included LINACLOTIDE (LINZESS) from 13-Apr-2022 to 19-May-2022 for an unknown indication.   On 18-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 16-May-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebounded with a positive COVID rapid test on 5/16 following numerous negative rapid tests). At the time of the report, COVID-19 (Rebounded with a positive COVID rapid test on 5/16 following numerous negative rapid tests) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) positive COVID rapid test. On an unknown date, SARS-CoV-2 test: negative (Negative) numerous negative rapid tests.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No allergic condition reported.  No treatment medication information provided.  Company Comment: This spontaneous case concerns a 61-year-old female patient, with co-suspect drug Paxlovid and concomitant drug Linaclotide, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred approximately 28 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient rebounded with a positive COVID-19 rapid test after completing treatment. The outcome of the event was reported as not resolved. The patient's medical history of co-suspect drug Paxlovid and concomitant drug Linaclotide, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female patient, with co-suspect drug Paxlovid and concomitant drug Linaclotide, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred approximately 28 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient rebounded with a positive COVID-19 rapid test after completing treatment. The outcome of the event was reported as not resolved. The patient's medical history of co-suspect drug Paxlovid and concomitant drug Linaclotide, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.