Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Suspected Covid-19 infection/Dry throat,Loss of taste; 1dose janssen,2dose moderna; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Suspected Covid-19 infection/Dry throat,Loss of taste) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1dose janssen,2dose moderna). On 16-Apr-2022, the patient experienced COVID-19 (Suspected Covid-19 infection/Dry throat,Loss of taste) (seriousness criterion medically significant). On 26-Apr-2022, COVID-19 (Suspected Covid-19 infection/Dry throat,Loss of taste) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1dose janssen,2dose moderna) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 20-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication information was provided. No treatment medication was provided. It was reported that on 12-Apr-2022 patient experienced dry throat. On 16-Apr-2022 the patient felt crummy and also tested positive for Covid-19. It was reported that within 2 days on 18-Apr-2022 throat resolved and patient felt 100 percent better.  This report was associated with a product quality complaint 90000229316. Company comment This spontaneous case concerns a 44-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of COVID-19, which occurred approximately 5 months after receiving a dose of mRNA-1273 vaccine, considered as the second dose of COVID 19 vaccination (booster dose, as she received JANSSEN COVID-19 VACCINE as primary vaccination). Patient experienced dry throat and ageusia. Had a positive SARS-CoV-2 test, and within 2 days throat resolved and patient felt 100 percent better. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of COVID-19, which occurred approximately 5 months after receiving a dose of mRNA-1273 vaccine, considered as the second dose of COVID 19 vaccination (booster dose, as she received JANSSEN COVID-19 VACCINE as primary vaccination). Patient experienced dry throat and ageusia. Had a positive SARS-CoV-2 test, and within 2 days throat resolved and patient felt 100 percent better. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.