Age: 55.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Interchange of vaccine products, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19; The patient had Janssen/J&J vaccine first then had Moderna vaccine; Tested positive for COVID/Sore throat/Achiness; The patient had Janssen/J&J vaccine first then had Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID/Sore throat/Achiness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Janssen/J&J vaccine first then had Moderna vaccine), COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient had Janssen/J&J vaccine first then had Moderna vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Janssen/J&J (Dose number: 1 and batch number: 1808978 with location of injection: right arm.) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen/J&J. Concurrent medical conditions included Sulfonamide allergy (Sulfa Allergy), Contrast media allergy (Contrast dye allergy), Chronic kidney disease, Asthma and Obesity.   On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Janssen/J&J vaccine first then had Moderna vaccine). On 12-May-2022 at 6:00 PM, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID/Sore throat/Achiness). On an unknown date, the patient experienced COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient had Janssen/J&J vaccine first then had Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID/Sore throat/Achiness) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Janssen/J&J vaccine first then had Moderna vaccine), COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient had Janssen/J&J vaccine first then had Moderna vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient race was reported as Caucasian. The patient was not taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid.  No concomitant medications were reported. It was reported that four days after completing Paxlovid treatment, the patient had sore throat, achiness and COVID. No treatment medications were reported.  Company comment: This spontaneous case concerns a 55-year-old female patient with no relevant medical history who experienced the unexpected non serious AESIs of COVID 19 unknown days and SARS-CoV-2 test positive approximately 6 months after the administration of a dose of mRNA-1273 vaccine. Patient was administered NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. 4 days later, patient experienced symptoms of sore throat and achiness and tested positive for COVID. Patient also received a dose of COVID-19 VACCINE NRVV AD26 approximately 6 months prior to mRNA-1273 vaccine (Inappropriate schedule of vaccine administered and interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with no relevant medical history who experienced the unexpected non serious AESIs of COVID 19 unknown days and SARS-CoV-2 test positive approximately 6 months after the administration of a dose of mRNA-1273 vaccine. Patient was administered NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. 4 days later, patient experienced symptoms of sore throat and achiness and tested positive for COVID. Patient also received a dose of COVID-19 VACCINE NRVV AD26 approximately 6 months prior to mRNA-1273 vaccine (Inappropriate schedule of vaccine administered and interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report.