Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Confirmed COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Confirmed COVID-19 infection) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Concurrent medical conditions included Carcinoma brain and Drug allergy (drug name not specified).   On 18-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Confirmed COVID-19 infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Jun-2022 to 02-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Confirmed COVID-19 infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive. On 02-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were provided. On 02-Jul-2022 patient tested negative for COVID-19 test after Paxlovid treatment for 5 days. On an unspecified date in Jul-2022 (5 days after Paxlovid treatment), patient started experiencing symptoms of coughing, congestion and low-grade fever. On 08-Jul-2022 (6 days after negative test), patient tested positive for Covid-19 virus test. The patient was treated with guaifenesin (Mucinex) and cough medication. Action taken with Paxlovid was reported as withdrawn. Company comment:  This is an spontaneous case concerning a 53-year-old female  patient with medical history of brain Carcinoma who experienced the seriousness criterion medically significant event of COVID-19 (AESI), unknown days  after receiving 3rd. dose of mRNA-1273 vaccine. On July, 8, 2022, SARS-CoV-2 test was performed with positive result  and the patient received Paxlovid co-suspect drug for 5 days;  after stop it, SARS-CoV-2 test result was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment:  This is an spontaneous case concerning a 53-year-old female  patient with medical history of brain Carcinoma who experienced the seriousness criterion medically significant event of COVID-19 (AESI), unknown days  after receiving 3rd. dose of mRNA-1273 vaccine. On July, 8, 2022, SARS-CoV-2 test was performed with positive result  and the patient received Paxlovid co-suspect drug for 5 days;  after stop it, SARS-CoV-2 test result was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.