Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 05-Oct-2022, the patient experienced COVID-19 (Tested positive for covid) (seriousness criterion medically significant). At the time of the report, COVID-19 (Tested positive for covid), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: (Positive) Positive. On 14-Oct-2022, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that Communication was PC File. There was a product complaint to report.  No treatment medication was provided.  Company Comment: This is a spontaneous case of revaccination with different COVID-19 vaccine and interchange of vaccine products for this female patient, of unknown age, with history of co-suspect administration of two doses of Comirnaty (Pfizer/BioNTech COVID-19 mRNA vaccine), who experienced the unexpected, serious (medically significant) event of COVID-19. The event occurred approximately 1 year, 8 months after receiving the second dose of Comirnaty and approximately 11 months after receiving a dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 original vaccine. It was reported that the patient tested positive for SARS-CoV-2 via home test. No symptoms were reported and treatment information was not provided. After 9 days, the patient tested negative for SARS-CoV-2 via home test. The history of co-suspect administration of two doses of Comirnaty remains a confounder. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report. The seriousness of the event COVID-19 was assessed as per the reporter's (Registered Nurse) assessment.; Sender's Comments: This is a spontaneous case of revaccination with different COVID-19 vaccine and interchange of vaccine products for this female patient, of unknown age, with history of co-suspect administration of two doses of Comirnaty (Pfizer/BioNTech COVID-19 mRNA vaccine), who experienced the unexpected, serious (medically significant) event of COVID-19. The event occurred approximately 1 year, 8 months after receiving the second dose of Comirnaty and approximately 11 months after receiving a dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 original vaccine. It was reported that the patient tested positive for SARS-CoV-2 via home test. No symptoms were reported and treatment information was not provided. After 9 days, the patient tested negative for SARS-CoV-2 via home test. The history of co-suspect administration of two doses of Comirnaty remains a confounder. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report. The seriousness of the event COVID-19 was assessed as per the reporter's (Registered Nurse) assessment.