Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19; Dose one administered on 13-JAN-2021 and dose 2 administered on 24-FEB-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 13-JAN-2021 and dose 2 administered on 24-FEB-2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010a21a and 025j20-2a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Fentanyl) and Iodine contrast media allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 13-JAN-2021 and dose 2 administered on 24-FEB-2021). In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 13-JAN-2021 and dose 2 administered on 24-FEB-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) positive 2 days after onset of symptoms., negative (Negative) negative on day 4 of Paxlovid treatment., positive (Positive) positive again on days 5 and 6., negative (Negative) negative days 7,8,and 9., positive (Positive) positive on day 10 and positive (Positive) positive with symptoms on day 14.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a 50-year-old female  patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 14 months after the administration of second dose of mRNA-1273 vaccine. Patient had a SARS-CoV-2 test positive and  was treated with Paxlovid. SARS-CoV-2 test was performed daily since diagnosis. At day 14 since start of COVID-19, patient had positive SARS-CoV-2 test result with symptoms.  Inappropriate schedule of product administration was captured, as interval between first and second dose was more than 35 days.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment.  The patient had COVID rebound and was still tested positive with symptoms since original start of symptoms (day 12 since first Paxlovid dose).; Sender's Comments: Company comment: This is a spontaneous case concerning a 50-year-old female  patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 14 months after the administration of second dose of mRNA-1273 vaccine. Patient had a SARS-CoV-2 test positive and  was treated with Paxlovid. SARS-CoV-2 test was performed daily since diagnosis. At day 14 since start of COVID-19, patient had positive SARS-CoV-2 test result with symptoms.  Inappropriate schedule of product administration was captured, as interval between first and second dose was more than 35 days.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.