Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Felt better during the 5 days and tested negative two days after treatment ended. Started to feel badly again on May 19 and and tested positive for Covid again on May 20) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 030m20a and 027a21a) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Chronic lymphocytic leukemia (Diagnosis about 10 years ago (have not received any treatment for this condition)) and Drug allergy (Unknown drug.). Concomitant products included ALLOPURINOL for an unknown indication. On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Felt better during the 5 days and tested negative two days after treatment ended. Started to feel badly again on May 19 and and tested positive for Covid again on May 20). At the time of the report, COVID-19 (Felt better during the 5 days and tested negative two days after treatment ended. Started to feel badly again on May 19 and and tested positive for Covid again on May 20) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-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. The patient taking other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 21-May-2022. The patient took Paxlovid for full 5 days of treatment for Covid-19. Company Comment: This spontaneous case concerns a 52-year-old male patient, with relevant medical history of Chronic lymphocytic leukemia, who experienced the unexpected AESI of COVID-19. The event occurred approximately 8 months 18 days after receiving the third dose of mRNA-1273 Vaccine (Primary doses - Moderna). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days, however 2 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The patient's medical history of Chronic lymphocytic leukemia, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient, with relevant medical history of Chronic lymphocytic leukemia, who experienced the unexpected AESI of COVID-19. The event occurred approximately 8 months 18 days after receiving the third dose of mRNA-1273 Vaccine (Primary doses - Moderna). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days, however 2 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The patient's medical history of Chronic lymphocytic leukemia, remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.