Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.   On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-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) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) positive. On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported. It was unknown whether patient was taking other medications/products within 2 weeks of starting COVID-19 treatment Patient previously received a COVID-19 Vaccine. It was reported that on 05-JUN-2022 after 7 days of completing paxlovid treatment course patient developed COVID symptoms and tested positive for COVID (after having tested negative previously). The outcome of the event was recovering/resolving. Device Date was reported as 06-Jun-2022.  Company Comment: This is a Spontaneous case concerning a 61-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an innapropiate schedule of primary vaccination). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 18-May-2022 for covid 19 treatment for 7 days. After 7 days completing the Paxlovid treatment, patient developed COVID symptoms and tested positive for COVID 19 (device date 06Jun2022). Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a Spontaneous case concerning a 61-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an innapropiate schedule of primary vaccination). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 18-May-2022 for covid 19 treatment for 7 days. After 7 days completing the Paxlovid treatment, patient developed COVID symptoms and tested positive for COVID 19 (device date 06Jun2022). Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.