Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Symptoms returned last night 5/26 8 days after patient tested positive. Patient tested this am ans am testing positive. Had tested negative on Sunday 5/22; Patient received first dose of Moderna vaccine on 26-Feb-2021 and second dose on 21-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms returned last night 5/26 8 days after patient tested positive. Patient tested this am ans am testing positive. Had tested negative on Sunday 5/22) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 26-Feb-2021 and second dose on 21-Mar-2021) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 013a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No drug reported).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 26-Feb-2021 and second dose on 21-Mar-2021). In May 2022, the patient experienced COVID-19 (Symptoms returned last night 5/26 8 days after patient tested positive. Patient tested this am ans am testing positive. Had tested negative on Sunday 5/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptoms returned last night 5/26 8 days after patient tested positive. Patient tested this am ans am testing positive. Had tested negative on Sunday 5/22) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 26-Feb-2021 and second dose on 21-Mar-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 22-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 26-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided by the reporter.  It was reported that, symptoms were returned last night on 26 May 2022, 8 days after patient tested positive. Patient tested positive this morning and evening. Patient had tested negative on Sunday 22 May 2022.   It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date : 27May2022. Company comment This is a spontaneous case concerning a 50-year-old patient of an unknown gender with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred approximately 2 months after the second dose of mRNA-1273. Inappropriate Schedule of Product Administration was considered an additional event. The patient completed a 5-days treatment with Paxlovid. The second day that the patient received Paxlovid, SARS-CoV-2 test was positive. It was reported that the symptoms returned 8 days after the patient tested positive and the patient had tested negative 4 days before. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 50-year-old patient of an unknown gender with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred approximately 2 months after the second dose of mRNA-1273. Inappropriate Schedule of Product Administration was considered an additional event. The patient completed a 5-days treatment with Paxlovid. The second day that the patient received Paxlovid, SARS-CoV-2 test was positive. It was reported that the symptoms returned 8 days after the patient tested positive and the patient had tested negative 4 days before. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.