Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy. Concurrent medical conditions included GERD and Factor V Leiden heterozygote ((heterozygous)). Concomitant products included WARFARIN SODIUM (COUMADIN) and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) negative. On 19-May-2022, SARS-CoV-2 antibody test: negative (Negative) negative. On 19-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 20-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 22-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 23-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 did take medications/products within 2 weeks of starting COVID-19 treatment. The Pfizer drug for COVID-19 treatment was started on 5 day course from 10-May-2022 to 14-May-2022. It was reported as, the initial symptoms largely abated on 13-May-2022. The patient had negative antigen test on 16-May-2022 and negative PCR 19-may-2022 but positive antigen test on same day. He started prednisone on 19-May-2022 and had slight cough and sniffle with no fever. He was tested positive for antigen tests on 20-May 22- May and 23-May-2022. Device Date was reported as 23-May-2022.  Company Comment: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination, and 13 months prior to the fourth mRNA-1273 vaccination. Patient was given a five-day-course of unspecified COVID-19 treatment for the initial COVID-19 infection, and tested negative for COVID-19 antigen after 2 days. However, five days after the COVID-19 treatment, patient had slight cough and sniffles with no fever, and was tested positive for COVID-19 antigen on the multiple days. Hence, patient started on prednisone. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination, and 13 months prior to the fourth mRNA-1273 vaccination. Patient was given a five-day-course of unspecified COVID-19 treatment for the initial COVID-19 infection, and tested negative for COVID-19 antigen after 2 days. However, five days after the COVID-19 treatment, patient had slight cough and sniffles with no fever, and was tested positive for COVID-19 antigen on the multiple days. Hence, patient started on prednisone. The benefit-risk relationship of mRNA-1273 is not affected by this report.