Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Confusional state, Dysstasia, Fear of death
Clinical narrative: hallucinating/delusional; thought she was going to die; scared to death; she could barely stand it; Caller might be confused or not thinking clearly; lucid; excruciatingly painful in the left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating/delusional) and NEAR DEATH EXPERIENCE (thought she was going to die) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 010M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), POTASSIUM, MELATONIN, ATORVASTATIN and LAMOTRIGINE (LAMOTRIGINE A) for an unknown indication, MEMANTINE HCL.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HALLUCINATION (hallucinating/delusional) (seriousness criterion medically significant), NEAR DEATH EXPERIENCE (thought she was going to die) (seriousness criterion medically significant), FEAR OF DEATH (scared to death), DYSSTASIA (she could barely stand it), CONFUSIONAL STATE (Caller might be confused or not thinking clearly), ABNORMAL DREAMS (lucid) and ARTHRALGIA (excruciatingly painful in the left shoulder). At the time of the report, HALLUCINATION (hallucinating/delusional), NEAR DEATH EXPERIENCE (thought she was going to die), FEAR OF DEATH (scared to death), DYSSTASIA (she could barely stand it), CONFUSIONAL STATE (Caller might be confused or not thinking clearly), ABNORMAL DREAMS (lucid) and ARTHRALGIA (excruciatingly painful in the left shoulder) outcome was unknown.            No treatment medication details was reported.  Company Comment: This case concerns a 73 year-old female patient with no reported medical history, on lamotrigine and memantine hydrochloride who experienced the unexpected serious event of hallucination and near death experience. The events occurred on an unknown date in the same month as the administration of the third dose of mRNA-1273.  The rechallenge was unknown as no additional dosing will be administered. The use of concomitant medication lamotrigine and memantine hydrochloride remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 73 year-old female patient with no reported medical history, on lamotrigine and memantine hydrochloride who experienced the unexpected serious event of hallucination and near death experience. The events occurred on an unknown date in the same month as the administration of the third dose of mRNA-1273.  The rechallenge was unknown as no additional dosing will be administered. The use of concomitant medication lamotrigine and memantine hydrochloride remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.