Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Janseen covid-19 vaccine (Left arm and Batch number: 014A21A) on 06-Apr-2021. Past adverse reactions to the above products included No adverse event with Janseen covid-19 vaccine.    On 06-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced COVID-19 (Tested positive for Covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Tested positive for Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported by patient.  On 26-May-2022, The patient had congestion and slight sore throat (suspected covid-19 infection)  The patient thought he had a cold later he developed a cough, body aches, back pain and his limbs feeling tired and achy.   This report was associated with product quality complaint for janssen vaccine:  No treatment medication was reported by patient.  Company Comment: This is a spontaneous case concerning a 41-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 (Tested positive for COVID-19), approximately 4 months after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine). The symptoms started with congestion and slight sore throat which later developed cough, body aches, back pain and limbs feeling tired and achy. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Interchange of vaccine products was also reported as the patient received primary dose of other COVID-19 vaccine (Janssen) approximately 9 months prior to the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 41-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 (Tested positive for COVID-19), approximately 4 months after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine). The symptoms started with congestion and slight sore throat which later developed cough, body aches, back pain and limbs feeling tired and achy. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Interchange of vaccine products was also reported as the patient received primary dose of other COVID-19 vaccine (Janssen) approximately 9 months prior to the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.