Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ cough/ not feeling so good; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19/ cough/ not feeling so good) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    In March 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19/ cough/ not feeling so good). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ cough/ not feeling so good) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and. On 15-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.   No concomitant medication was provided. It was reported that  the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that 5 days after completing treatment of Paxlovid patient was feeling good. Patient even had two negative PCR tests. 6 or 7 days later patient reported that it started with a cough, not feeling so good and had a positive rapid and PCR test.. Device date: 23-May-2022  Company Comment: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative to PCR test after treatment completion. Approximately 6-7 days after the treatment, patient reported to develop a cough, did not feel good and tested positive in rapid and PCR test. The event had not resolved at the time of the report. It should be noted that the dose was reported as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative to PCR test after treatment completion. Approximately 6-7 days after the treatment, patient reported to develop a cough, did not feel good and tested positive in rapid and PCR test. The event had not resolved at the time of the report. It should be noted that the dose was reported as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.