Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID -19; Tested Positive for COVID -19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (Tested Positive for COVID -19), the second episode of COVID-19 (Tested Positive for COVID -19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 058E21A, 010A21SA and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included DVT and Pulmonary embolism. Concurrent medical conditions included Drug allergy. Concomitant products included WARFARIN SODIUM (COUMADIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 30-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the first episode of COVID-19 (Tested Positive for COVID -19). On 09-May-2022, the patient experienced the second episode of COVID-19 (Tested Positive for COVID -19). On 14-May-2022, last episode of COVID-19 (Tested Positive for COVID -19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 14-May-2022, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had COVID symptoms as chills, sore throat, running nose and congestion.  The patient reported symptoms dissipated with no further COVID treatment medication.  Device date was reported as 16-May-2022  Company Comment: This is a spontaneous case concerning a 58-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19. The patient reported symptoms of chills, sore throat, runny nose with congestion and tested positive for COVID rapid test 30 days after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative with rapid test. After 9 days from the date of the positive test, the symptoms recurred and tested positive again on rapid test. The symptoms were dissipating, no medications given and tested negative on rapid test after 5 days. Inappropriate schedule of product administration was also noted as the primary doses of mRNA-1273 were given on a 37-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19. The patient reported symptoms of chills, sore throat, runny nose with congestion and tested positive for COVID rapid test 30 days after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative with rapid test. After 9 days from the date of the positive test, the symptoms recurred and tested positive again on rapid test. The symptoms were dissipating, no medications given and tested negative on rapid test after 5 days. Inappropriate schedule of product administration was also noted as the primary doses of mRNA-1273 were given on a 37-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.