Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 22-Apr-2022 at 2:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 11-May-2022 to 15-May-2022 for COVID-19 immunisation, at an unspecified dose and frequency. On 16-May-2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative home antigen test on Day 6 since initial positive test. On 21-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 24-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient did not receive any treatment for the event COVID-19 recurrent. It was reported that mild symptoms continuing as of day 14 (24-May-2022).  Company Comment:  This spontaneous case concerns a 71-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test), that occurred 19 days after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and tested negative the next day. However, patient presented rebound sore throat, nasal congestion, and fatigue 5 days after (day 10 since initial diagnosis of COVID-19) documented by  two subsequent positive COVID-19 tests.  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test), that occurred 19 days after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and tested negative the next day. However, patient presented rebound sore throat, nasal congestion, and fatigue 5 days after (day 10 since initial diagnosis of COVID-19) documented by  two subsequent positive COVID-19 tests.  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine The benefit-risk relationship of mRNA-1273 is not affected by this report.