Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: developed reinfection of covid w in one week after testing negative several times reinfection occurred; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed reinfection of covid w in one week after testing negative several times reinfection occurred) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (unknown drug). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 03-May-2022, the patient experienced COVID-19 (developed reinfection of covid w in one week after testing negative several times reinfection occurred). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing from May 2022 for COVID-19 recurrent, at an unspecified dose and frequency. At the time of the report, COVID-19 (developed reinfection of covid w in one week after testing negative several times reinfection occurred) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative several times.         Patient's race was reported as black.  It was reported that, on 15-May-2022, the patient developed reinfection of COVID-19 within 8 days of clearing the last infection. The patient started another round of Paxlovid for the adverse event.  Company comment: This spontaneous case concerns a 61-year-old female patient, with no reported relevant medical history, who experienced, unexpected, non-serious AESI of COVID-19, approximately 13 months after receiving mRNA-1273 vaccine as a second dose.  Inappropriate schedule of vaccine administered is also reported in this case as an additional event.  Dose 1 and Dose 2 were given with a 13-day interval which is not within the recommended dosing window.  The patient was started with Nirmatrevlir-Ritonavir (Paxlovid) at an unspecified dose and frequency for 5 days. The patient was reported to have been tested negative several times with unspecified COVID-19 test.  7 days after completing the course of Paxlovid, the patient reported reinfection of COVID-19 requiring another course of Paxlovid.  The event had not resolved.    The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female patient, with no reported relevant medical history, who experienced, unexpected, non-serious AESI of COVID-19, approximately 13 months after receiving mRNA-1273 vaccine as a second dose.  Inappropriate schedule of vaccine administered is also reported in this case as an additional event.  Dose 1 and Dose 2 were given with a 13-day interval which is not within the recommended dosing window.  The patient was started with Nirmatrevlir-Ritonavir (Paxlovid) at an unspecified dose and frequency for 5 days. The patient was reported to have been tested negative several times with unspecified COVID-19 test.  7 days after completing the course of Paxlovid, the patient reported reinfection of COVID-19 requiring another course of Paxlovid.  The event had not resolved.    The benefit-risk relationship of mRNA-1273 is not affected by this report.