Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Tested positive after Moderna Dose 4; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive after Moderna Dose 4) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l21B) for COVID-19 vaccination.     Patient had allergic reaction to unspecified drug.  The patient's past medical history included Drug allergy.    On 26-Mar-2022 at 12:15 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive after Moderna Dose 4). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive after Moderna Dose 4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive (on an Home antigen test). In 2022, SARS-CoV-2 antibody test: positive (Positive) Positive (first occurrence).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was unknown if patient was taking other medications or products within 2 weeks of starting COVID-19 treatment.  Patient previously received a COVID-19 vaccine.  Device date was reported as 22 May 2022.  Company Comment: This spontaneous case concerns a 66-year-old, male 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 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. No symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 09May2022 to 13May2022. It was reported that 5 days after the last dose of Paxlovid, the patient again tested positive for SARS-CoV-2 via a Home Antigen test. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old, male 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 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. No symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 09May2022 to 13May2022. It was reported that 5 days after the last dose of Paxlovid, the patient again tested positive for SARS-CoV-2 via a Home Antigen test. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.