Age: 42.0
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; COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (No drug was reported.).   On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) Unknown. 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 (COVID-19) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine). At the time of the report, COVID-19 (COVID-19) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2022, SARS-CoV-2 test: (Negative) negative. On 10-Jul-2022, SARS-CoV-2 test: (Negative) negative. On 11-Jul-2022, SARS-CoV-2 test: (Negative) negative. On 12-Jul-2022, SARS-CoV-2 test: (Negative) negative. On 14-Jul-2022, SARS-CoV-2 test: (Positive) positive.         The patient experienced COVID-19 with mild symptoms. The patient had clinical vaccination failure (dose number in series 1). On 14-Jul-2022, patient woke up with rebound infection with symptoms of sore throat.  No concomitant medications were reported. The reporter and manufacturer causality for event Covid-19 for co-suspect COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) was reported as possible.  Company Comment: This is a spontaneous case concerning a 42 year old female patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine, interchange of vaccine products event was noted in the case. The patient received Paxlovid co-suspect drug for 5 days;  after stopping it, SARS-CoV-2 test result was positive. At the time of the report, COVID-19 (COVID-19) had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42 year old female patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine, interchange of vaccine products event was noted in the case. The patient received Paxlovid co-suspect drug for 5 days;  after stopping it, SARS-CoV-2 test result was positive. At the time of the report, COVID-19 (COVID-19) had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.