Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (DXed on May 20, started Paxlovid. May 20 and 21 symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness, high pulse. May 22 most resolved, pulmonary weakness, high pulse, some fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No known drug allergy were reported. The patient's past medical history included Chemotherapy (chemo at 30). Concurrent medical conditions included Cancer (Cancer at 24 and 30 (chemo at 30).) and Diabetes (well-managed at 6.2 A1c). Concomitant products included Lisinopril; Atorvastatin; Metformin; Ozempic; and Testosterone for an unknown indication. On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced COVID-19 (DXed on May 20, started Paxlovid. May 20 and 21 symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness, high pulse. May 22 most resolved, pulmonary weakness, high pulse, some fatigue). 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. At the time of the report, COVID-19 (DXed on May 20, started Paxlovid. May 20 and 21 symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness, high pulse. May 22 most resolved, pulmonary weakness, high pulse, some fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Heart rate: high (High) High. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 24-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Oxygen saturation: 92 (Low) Oxygen is often around 92 and then with deep breaths went up to 95. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company comment: This is a spontaneous case concerning a 54-year-old male  patient with diabetes, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 6 months after an unspecified dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness and high pulse. Patient started treatment with Paxlovid and most of the symptoms resolved after two days. At day 10 after starting COVID-19, patient had stuffiness, slight fever, pulmonary weakness, and tested positive for SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Date of birth of patient was given as DEC-1967. Other concomitant medication substance included testosterone replacement gel. Patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. It was reported that on 20-MAY-2022 and 21-MAY-2022 symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness, high pulse. On 22-May-2022 onward most resolved, other than pulmonary weakness and high pulse, some fatigue. Tested negative on 24-May-2022, 25-May-2022, 28-May-2022. On 30-May-2022 started noticing stuffiness, tested positive (rebound) in morning on 31-May-2022, slight fever, some stuffiness, pulmonary weakness continued but not worsened. Device Date was 31-May-2022. Sender's Comments: Company comment: This is a spontaneous case concerning a 54-year-old male  patient with diabetes, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 6 months after an unspecified dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Symptoms included achiness, fever, sore throat, nausea, diarrhea, fatigue, pulmonary weakness and high pulse. Patient started treatment with Paxlovid and most of the symptoms resolved after two days. At day 10 after starting COVID-19, patient had stuffiness, slight fever, pulmonary weakness, and tested positive for SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.