Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Interchange of vaccine products, Paraesthesia, SARS-CoV-2 test
Clinical narrative: I fainted next to the window/I tried to move than I needed more fresh air; Very short, really strange condition (my body was made up only of dots, I couldn't see a real body)"; Pins and needles came helically from my feet upwards; got Moderna as 3. vaccine (1-2. - Sputnik - was 7 months ago); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I fainted next to the window/I tried to move than I needed more fresh air) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hemangioma of liver (I haven' t got allergy or any disease except small liver hemangioma.). Previously administered products included for Product used for unknown indication: Sputnik (first two doses 7 months ago). Past adverse reactions to the above products included No adverse event with Sputnik.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I fainted next to the window/I tried to move than I needed more fresh air) (seriousness criterion medically significant), FEELING ABNORMAL (Very short, really strange condition (my body was made up only of dots, I couldn't see a real body)"), PARAESTHESIA (Pins and needles came helically from my feet upwards) and INTERCHANGE OF VACCINE PRODUCTS (got Moderna as 3. vaccine (1-2. - Sputnik - was 7 months ago)). At the time of the report, DYSPNOEA (I fainted next to the window/I tried to move than I needed more fresh air) and PARAESTHESIA (Pins and needles came helically from my feet upwards) outcome was unknown and FEELING ABNORMAL (Very short, really strange condition (my body was made up only of dots, I couldn't see a real body)") and INTERCHANGE OF VACCINE PRODUCTS (got Moderna as 3. vaccine (1-2. - Sputnik - was 7 months ago)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID test made by the ambulance man was negative.         Patient got Sputnik vaccine 7 months ago as dose 1 and dose 2. No concomitant medication information was provided. No treatment medication was provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced Interchange of vaccine products and the unexpected serious (medically significant) event of Syncope after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received initial schedule of vaccination with Sputnik Vaccine 7 months before. The event occurred approximately 1 day after the dose of mRNA- 1273 vaccine. Ambulance was called, but very little information is available regarding diagnostic work-up and clinical course. The rechallenge is not applicable, since the patient received only one dose of mRNA- 1273 Moderna vaccine. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced Interchange of vaccine products and the unexpected serious (medically significant) event of Syncope after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received initial schedule of vaccination with Sputnik Vaccine 7 months before. The event occurred approximately 1 day after the dose of mRNA- 1273 vaccine. Ambulance was called, but very little information is available regarding diagnostic work-up and clinical course. The rechallenge is not applicable, since the patient received only one dose of mRNA- 1273 Moderna vaccine. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report