Age: 69.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Lethargy, Loss of consciousness
Clinical narrative: patient was being lethargic/was bed ridden for 2 weeks; immediate reaction of passing out and this happened at the immunization site; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (immediate reaction of passing out and this happened at the immunization site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 004F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication and ALPRAZOLAM for Sleep disorder NOS.    Concurrent medical conditions included Sleep disorder NOS, Depression and Anxiety.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started FLUOXETINE HYDROCHLORIDE (PROZAC) (unknown route) 80 microgram and ALPRAZOLAM (unknown route) 1 microgram at bedtime. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (immediate reaction of passing out and this happened at the immunization site) (seriousness criterion medically significant). On an unknown date, the patient experienced LETHARGY (patient was being lethargic/was bed ridden for 2 weeks). On 29-Apr-2021, LOSS OF CONSCIOUSNESS (immediate reaction of passing out and this happened at the immunization site) had resolved. At the time of the report, LETHARGY (patient was being lethargic/was bed ridden for 2 weeks) outcome was unknown.            No concomitant medication was reported. After receiving second dose, patient reports an immediate reaction of passing out and this happened at the immunization site. The patient was able to drive home and went home and was bed ridden for 2 weeks. After receiving third dose, patient was lethargic for about two months.  The patient stated that he had taken antidepressants and psychotropic drugs for anxiety and depression, and he believed that these medications increased his lethargy after the Moderna Covid-19 vaccine.  The patient received the RSV vaccine one week ago. The injections site to the RSV was in a deep tissue injection site and the injection site hurt a great deal. The patient also received the flu shot, Tetanus shot and Pneumococcal vaccine on the same date. The patient had extreme lethargy to the Pneumococcal vaccine only.  Company comment : This is a spontaneous case concerning a 69-year-old male patient with relevant medical history of anxiety and depression, under antidepressants and psychotropic drugs, who experienced a serious (due to medically significant) unexpected event of Loss of consciousness, and a non-serious unexpected event of lethargy. The event Loss of consciousness occurred on the same day, at the immunization site, after the second dose of mRNA-1273 vaccine administration, and the event lethargy occurred within 2 weeks after vaccination. As reported, after passing out, the patient was able to drive home and went home and was bed ridden for 2 weeks. Clinical course, supportive diagnostic procedures, and treatment, if any were not provided. The patient believed that antidepressants and psychotropic drugs increased his lethargy after the Moderna Covid-19 vaccine, and he also reported that he had extreme lethargy to the Pneumococcal vaccine only. The outcome of the event Loss of consciousness was reported as resolved, and for lethargy was unknown. Antidepressants and psychotropic drugs are confounders for the event lethargy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-750782, MOD-2023-750747 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning a 69-year-old male patient with relevant medical history of anxiety and depression, under antidepressants and psychotropic drugs, who experienced a serious (due to medically significant) unexpected event of Loss of consciousness, and a non-serious unexpected event of lethargy. The event Loss of consciousness occurred on the same day, at the immunization site, after the second dose of mRNA-1273 vaccine administration, and the event lethargy occurred within 2 weeks after vaccination. As reported, after passing out, the patient was able to drive home and went home and was bed ridden for 2 weeks. Clinical course, supportive diagnostic procedures, and treatment, if any were not provided. The patient believed that antidepressants and psychotropic drugs increased his lethargy after the Moderna Covid-19 vaccine, and he also reported that he had extreme lethargy to the Pneumococcal vaccine only. The outcome of the event Loss of consciousness was reported as resolved, and for lethargy was unknown. Antidepressants and psychotropic drugs are confounders for the event lethargy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.