Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; It was reported that patient experienced COVID-19 on mid of Aug-2022 after getting 3 doses of the Moderna COVID-19 vaccine and one dose of Pfizer; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (It was reported that patient experienced COVID-19 on mid of Aug-2022 after getting 3 doses of the Moderna COVID-19 vaccine and one dose of Pfizer), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002A21A and 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (It was reported that patient experienced COVID-19 on mid of Aug-2022 after getting 3 doses of the Moderna COVID-19 vaccine and one dose of Pfizer). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (It was reported that patient experienced COVID-19 on mid of Aug-2022 after getting 3 doses of the Moderna COVID-19 vaccine and one dose of Pfizer), 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): In August 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Company comment: This spontaneous case reported by a physician concerns a 76-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. The event occurred approximately 9 months after the third dose of mRNA-1273 Vaccine and approximately 3 months after tozinameran given as fourth dose. Other details are not available. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were considered as additional events as fourth dose was given with Tozinameran vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-642055 (E2B Linked Report).; Sender's Comments: This spontaneous case reported by a physician concerns a 76-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. The event occurred approximately 9 months after the third dose of mRNA-1273 Vaccine and approximately 3 months after tozinameran given as fourth dose. Other details are not available. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were considered as additional events as fourth dose was given with Tozinameran vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-642055:Crosslinked with AE (Husband's Case)