Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fear, Near death experience, Tongue injury
Clinical narrative: almost killed /it was insane; Anaphylactic reaction; the swelling crack the surface of my tongue; Very frightened; This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (almost killed /it was insane) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 NEAR DEATH EXPERIENCE (almost killed /it was insane) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TONGUE INJURY (the swelling crack the surface of my tongue) and FEAR (Very frightened). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 100 milligram, a time. At the time of the report, NEAR DEATH EXPERIENCE (almost killed /it was insane), ANAPHYLACTIC REACTION (Anaphylactic reaction), TONGUE INJURY (the swelling crack the surface of my tongue) and FEAR (Very frightened) outcome was unknown.            Have no epipen downed large amounts of Benadryl. Patient administered Moderna booster dose.  No concomitant medication was provided.  Company Comment: This regulatory authority case concerns a 72 year old patient with unknown gender with no medical history reported who experienced Serious ( medially significant ) , expected event of anaphylactic reaction and serious  ( medically significant )  , unexpected event of near death experience .Other non-serious , unexpected  events of  tongue injury and fear occurred on an unknown date post vaccination with an unknown dose number of mRNA-1273 vaccine  . This patient was treated with diphenhydramine hydrocholoride at a dose of 100 mg. Other details surrounding the events were not reported like medical consult / ER visit , results of laboratories/diagnostic procedures.  At the time of this report events' outcome  were reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 72 year old patient with unknown gender with no medical history reported who experienced Serious ( medially significant ) , expected event of anaphylactic reaction and serious  ( medically significant )  , unexpected event of near death experience .Other non-serious , unexpected  events of  tongue injury and fear occurred on an unknown date post vaccination with an unknown dose number of mRNA-1273 vaccine  . This patient was treated with diphenhydramine hydrocholoride at a dose of 100 mg. Other details surrounding the events were not reported like medical consult / ER visit , results of laboratories/diagnostic procedures.  At the time of this report events' outcome  were reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.