Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive 2X on May 20, 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive 2X on May 20, 2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 033H21A, 088D21A, 012M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included HPB and BMI was mentioned as 30.  Concurrent medical conditions included Drug allergy (Unknown historical drug.).   On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022 at 12:00 PM, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive 2X on May 20, 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (Tested positive 2X on May 20, 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.         No concomitant medication information was provided.  The patient  was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient did previously receive a COVID-19 Vaccine.  It was reported that patient after taking Paxlovid Rebound tested positive 2 times on 20 May 2022 and experienced  throat tickle only symptom. Commenced Plaxlovid 20 May 2022 completed 5 pay program per instructions.  Patient experienced sore throat on 20 May 2022 to 22 May 2022 and symptoms resolved.  Patient tested negative on 23 May 2022 through 29 May 2022 again tested positive on 30 May 2022 through on 05 Jun 2022  Patient had  slight cough commenced on 30 May and resolved in 2 days.  Patient never had a fever.  Device date was reported was 05 Jun 2022  Company comment. This spontaneous case reported by a patient, concerns a 75  year  old male patient with no relevant medical history, who experienced the unexpected non  serious AESI of COVID-19 infection, 3 days after receiving the fifth dose of mRNA-1273 vaccine. It was reported that the patient had a tickle in the throat, tested positive and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for five days. Sore throat lasted two days, he had a negative test and mentioned the symptoms resolved. Approximately one week later he had a slight cough and had a new positive test. No further information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns a 75  year  old male patient with no relevant medical history, who experienced the unexpected non  serious AESI of COVID-19 infection, 3 days after receiving the fifth dose of mRNA-1273 vaccine. It was reported that the patient had a tickle in the throat, tested positive and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for five days. Sore throat lasted two days, he had a negative test and mentioned the symptoms resolved. Approximately one week later he had a slight cough and had a new positive test. No further information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.