Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After initial significant clinical improvement and negative home test, COVID symptoms (nasal discharge, sneezing, coughing) returned in the evening of 5/22/2022. Home test, confirmed on 5/23/2022; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (After initial significant clinical improvement and negative home test, COVID symptoms (nasal discharge, sneezing, coughing) returned in the evening of 5/22/2022. Home test, confirmed on 5/23/2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Renal calculus. Previously administered products included for Product used for unknown indication: Procaine (Procaine) and Penicillin (Penicillin). Past adverse reactions to the above products included Allergy with Penicillin and Procaine. Concurrent medical conditions included Benign prostatic hypertrophy, Hypercholesterolemia and Osteoarthritis.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022 at 5:30 PM, the patient experienced COVID-19 (After initial significant clinical improvement and negative home test, COVID symptoms (nasal discharge, sneezing, coughing) returned in the evening of 5/22/2022. Home test, confirmed on 5/23/2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (After initial significant clinical improvement and negative home test, COVID symptoms (nasal discharge, sneezing, coughing) returned in the evening of 5/22/2022. Home test, confirmed on 5/23/2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Home test,: with a NAAT at pharmacy', were positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The patient hadn't taken any other medications/products within 2 weeks of starting COVID-19 treatment. Treatment information was not reported. Company comment: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI. The event occurred 18 days after administration of fourth dose of mRNA-1273. The patient was treated with Nirmatrelvir and Paxlovid for 5 days of unspecified dose and frequency. On May 23, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI. The event occurred 18 days after administration of fourth dose of mRNA-1273. The patient was treated with Nirmatrelvir and Paxlovid for 5 days of unspecified dose and frequency. On May 23, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.