Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Immunisation reaction, Near death experience
Clinical narrative: felt like was going to die, within a few minutes after 2nd shot; Diagnosed with Gout after second shot; second vaccine messed up; This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (felt like was going to die, within a few minutes after 2nd shot) in a 53-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.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NEAR DEATH EXPERIENCE (felt like was going to die, within a few minutes after 2nd shot) (seriousness criterion medically significant), GOUT (Diagnosed with Gout after second shot) and IMMUNISATION REACTION (second vaccine messed up). At the time of the report, NEAR DEATH EXPERIENCE (felt like was going to die, within a few minutes after 2nd shot), GOUT (Diagnosed with Gout after second shot) and IMMUNISATION REACTION (second vaccine messed up) outcome was unknown.            No concomitant medications were reported.  It was reported that, patient called and they could not help her. She did not had her vaccination card handy. She stated that, within a few minutes after 2nd shot, she felt like she was going to die. In the Hospital she was diagnosed with Gout.  No treatment medications were reported. Company Comment: This spontaneous case concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of Near death experience (reported as FELT LIKE WAS GOING TO DIE, WITHIN A FEW MINUTES AFTER 2ND SHOT), which occurred few minutes after 2nd dose mRNA-1273 administration. The event was accompanied by non-serious events of Gout and Immunisation reaction (reported as SECOND VACCINE MESSED UP). No further clinical information or details about course of the event was provided for medical review. The outcome of the event was not known at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event's seriousness was assessed as per the Regulatory Agency list of important medical events.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of Near death experience (reported as FELT LIKE WAS GOING TO DIE, WITHIN A FEW MINUTES AFTER 2ND SHOT), which occurred few minutes after 2nd dose mRNA-1273 administration. The event was accompanied by non-serious events of Gout and Immunisation reaction (reported as SECOND VACCINE MESSED UP). No further clinical information or details about course of the event was provided for medical review. The outcome of the event was not known at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event's seriousness was assessed as per the Regulatory Agency list of important medical events.