Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nasal discomfort, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Burning nose; Watery eyes; Headache; home antigen test and positive for COVID-19 tested as positive; Runny nose; Fatigue; Nasal congestion; Interchange of vaccine product; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (home antigen test and positive for COVID-19 tested as positive), RHINORRHOEA (Runny nose), FATIGUE (Fatigue), NASAL CONGESTION (Nasal congestion), NASAL DISCOMFORT (Burning nose), LACRIMATION INCREASED (Watery eyes) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 06-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 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product). On 14-Dec-2021, the patient experienced COVID-19 (home antigen test and positive for COVID-19 tested as positive) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NASAL CONGESTION (Nasal congestion) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 15-Dec-2021, the patient experienced NASAL DISCOMFORT (Burning nose) (seriousness criterion medically significant) and LACRIMATION INCREASED (Watery eyes) (seriousness criterion medically significant). On 17-Dec-2021, HEADACHE (Headache) had resolved. On 18-Dec-2021, NASAL DISCOMFORT (Burning nose) and LACRIMATION INCREASED (Watery eyes) had resolved. On 20-Dec-2021, NASAL CONGESTION (Nasal congestion) had resolved. At the time of the report, COVID-19 (home antigen test and positive for COVID-19 tested as positive), RHINORRHOEA (Runny nose) and FATIGUE (Fatigue) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant and treatment information was provided.  Company comment: This is a spontaneous case concerning a 54-year-old male patient with no medical history reported, who experienced serious, unexpected events of COVID-19 (AESI), rhinorrhoea, fatigue, nasal congestion, nasal discomfort, lacrimation increased and headache. On 06-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE). On 02-Nov-2021, the patient received second dose of mRNA-1273 vaccine. The events COVID-19,  rhinorrhoea, fatigue, nasal congestion and headache occurred 42 days after the administration of second dose of mRNA-1273 vaccine. The events nasal discomfort and lacrimation increased occurred 43 days after the administration of second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no medical history reported, who experienced serious, unexpected events of COVID-19 (AESI), rhinorrhoea, fatigue, nasal congestion, nasal discomfort, lacrimation increased and headache. On 06-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE). On 02-Nov-2021, the patient received second dose of mRNA-1273 vaccine. The events COVID-19,  rhinorrhoea, fatigue, nasal congestion and headache occurred 42 days after the administration of second dose of mRNA-1273 vaccine. The events nasal discomfort and lacrimation increased occurred 43 days after the administration of second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.