Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; Suspected Covid-19 Infection; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (Suspected Covid-19 Infection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) 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.    The patient had no history of drug abuse or illicit drug use.  Concurrent medical conditions included Asthma, Alcohol use (1-2 glasses per month), Non-smoker, Seasonal allergy and Drug allergy (hives).   On 03-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced SUSPECTED COVID-19 (Suspected Covid-19 Infection) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 24-Feb-2022, SUSPECTED COVID-19 (Suspected Covid-19 Infection) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported reporter was patient (company employee of jansen). Patient took Janssen vaccine at the age of 40 years. No concomitant product was provided. The vaccination failure was reported for Janssen vaccine and outcome was not reported. Event causality of both the event suspected covid-19 and vaccination failure were reported as possible, by reported also by jansen.  No treatment information were reported. Company comment: This spontaneous case concerns a 41-year-old female, with no relevant medical history, who experienced the serious (due to medically significant) unexpected AESI of COVID-19, approximately 3 months after the dose of mRNA-12373 vaccine, considered as the second dose of the vaccine schedule. Previously she received a dose of Janssen COVID-19 vaccine as the first dose: Interchange of vaccine products case. A positive SARS-CoV-2 test confirmed the diagnose. No treatment information were reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female, with no relevant medical history, who experienced the serious (due to medically significant) unexpected AESI of COVID-19, approximately 3 months after the dose of mRNA-12373 vaccine, considered as the second dose of the vaccine schedule. Previously she received a dose of Janssen COVID-19 vaccine as the first dose: Interchange of vaccine products case. A positive SARS-CoV-2 test confirmed the diagnose. No treatment information were reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.