Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive on 08-May-2022/Tested positive again on 19-May-2022; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive on 08-May-2022/Tested positive again on 19-May-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 26-Feb-2021 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive on 08-May-2022/Tested positive again on 19-May-2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive on 08-May-2022/Tested positive again on 19-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 test: positive (Positive) tested positive. On 19-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 19May2022.  Company Comment: This spontaneous case concerns a 62-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred approximately 1 year, 2 months after receiving an unspecified dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. No symptoms were reported. She took and completed a 10-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 17May2022. However, the outcome of the event was unknown at the time of the report. After 2 days, it was reported that the patient again tested positive for SARS-CoV-2. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred approximately 1 year, 2 months after receiving an unspecified dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. No symptoms were reported. She took and completed a 10-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 17May2022. However, the outcome of the event was unknown at the time of the report. After 2 days, it was reported that the patient again tested positive for SARS-CoV-2. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.