Age: 74.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Had COVID-19 symptoms; Had some side effects not extreme like nausea overall not feeling good and today I just don't feel good/Started feeling better and then by January one,Ain't feel so great but not terr ble.; was not that sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19 symptoms), MALAISE (Had some side effects not extreme like nausea overall not feeling good and today I just don't feel good/Started feeling better and then by January one,Ain't feel so great but not terr ble.) and ILLNESS (was not that sick) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Heart disease, unspecified.   In December 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had COVID-19 symptoms), MALAISE (Had some side effects not extreme like nausea overall not feeling good and today I just don't feel good/Started feeling better and then by January one,Ain't feel so great but not terr ble.) and ILLNESS (was not that sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 3 days. At the time of the report, COVID-19 (Had COVID-19 symptoms) outcome was unknown and MALAISE (Had some side effects not extreme like nausea overall not feeling good and today I just don't feel good/Started feeling better and then by January one,Ain't feel so great but not terr ble.) and ILLNESS (was not that sick) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive.         No concomitant medications were reported. Patient received Moderna as Booster.Reported that patient  was perfectly alright. Patient had COVID symptoms last,  actually last Wednesday started feeling better and then by January one which was Saturday did not felt so great but not terrible. Company comment: This spontaneous case concerns a 74-years-old patient of unspecified gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine and first dose of JANSSEN COVID-19 VACCINE the co-suspect with SARS-CoV-2 antibody test Positive. Patient received third dose with of mRNA-1273 vaccine There is interchange of vaccine product was noted. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 3 days. No additional details of clinical course, concomitant medication was not provided. The event outcome was resolving. Ongoing pandemic remains a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: This spontaneous case concerns a 74-years-old patient of unspecified gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine and first dose of JANSSEN COVID-19 VACCINE the co-suspect with SARS-CoV-2 antibody test Positive. Patient received third dose with of mRNA-1273 vaccine There is interchange of vaccine product was noted. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 3 days. No additional details of clinical course, concomitant medication was not provided. The event outcome was resolving. Ongoing pandemic remains a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.