Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient was treated with Paxlovid for COVID-19 treatment/ Rebound symptoms 5 days after Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient was treated with Paxlovid for COVID-19 treatment/ Rebound symptoms 5 days after Paxlovid treatment) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PNEUMOCOCCAL VACCINE. Past adverse reactions to the above products included Allergy with PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Type 1 diabetes mellitus.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was treated with Paxlovid for COVID-19 treatment/ Rebound symptoms 5 days after Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient was treated with Paxlovid for COVID-19 treatment/ Rebound symptoms 5 days after Paxlovid treatment) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was reported. No information on concomitant medication was reported. Patient was treated with Paxlovid for COVID-19 (symptoms included nasal drainage, cough, headache and fatigue). On 25-MAY-2022, 5 days after completion of Paxlovid, the patient experienced rebound symptoms of nasal drainage, cough, headache and fatigue. No treatment medication given for rebound symptoms post treatment with Paxlovid. Company comment: This spontaneous case concerns a 50-year-old, female patient with medical history of Type I Diabetes Mellitus, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed. There was no information provided regarding the initial two doses. The patient experienced symptoms of nasal drainage, cough, headache and fatigue, started treatment regimen of Nirmatrelvir and Paxlovid on May 16-20, 2022, 5 days after completion the patient experienced rebound symptoms. Details of concomitant medications, clinical course 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 50-year-old, female patient with medical history of Type I Diabetes Mellitus, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed. There was no information provided regarding the initial two doses. The patient experienced symptoms of nasal drainage, cough, headache and fatigue, started treatment regimen of Nirmatrelvir and Paxlovid on May 16-20, 2022, 5 days after completion the patient experienced rebound symptoms. Details of concomitant medications, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.