Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of consciousness, Loss of personal independence in daily activities, Multiple sclerosis, Urinary tract infection
Clinical narrative: was so week, so spatial disoriented/was so weak and didn't fall flat on their back/became very weak, and went to lay down; did not felt good/ bad falling /first episode was within 48 hours after getting the vaccine,; couldn't see clearly/was like having oil in their eyes/eyes balance and been weak.; was very blurry/ vision was so bad that kept running into walls; couldn't eat anything; couldn't cook; like a MS symptoms/ bad MS attack; in the hospital they discover they have a urine infection; felt 5 times in two weeks/End it up in the Emergency room with a concussion from falling out from  a electric wheel chair,; felt form their wheel chair and was unconscious for more than 1hours and 30 minutes; Concussion; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (felt form their wheel chair and was unconscious for more than 1hours and 30 minutes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident automobile (The patient had car accident in 90's), MS (7 years ago. 8 years ago got MS, have bad vison and couldn't speak clearly and weakness,), Spinal cord injury and Injury. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1.) and Pfizer (Dose 2.). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to morphine sulfate) and Drug allergy (Allergy to Remeron.).    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (felt form their wheel chair and was unconscious for more than 1hours and 30 minutes) (seriousness criterion medically significant), FALL (felt 5 times in two weeks/End it up in the Emergency room with a concussion from falling out from  a electric wheel chair,) and CONCUSSION (Concussion). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (like a MS symptoms/ bad MS attack), URINARY TRACT INFECTION (in the hospital they discover they have a urine infection), ASTHENIA (was so week, so spatial disoriented/was so weak and didn't fall flat on their back/became very weak, and went to lay down), FEELING ABNORMAL (did not felt good/ bad falling /first episode was within 48 hours after getting the vaccine,), VISUAL IMPAIRMENT (couldn't see clearly/was like having oil in their eyes/eyes balance and been weak.), VISION BLURRED (was very blurry/ vision was so bad that kept running into walls), FEEDING DISORDER (couldn't eat anything) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't cook). On 29-Jan-2022, CONCUSSION (Concussion) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (felt form their wheel chair and was unconscious for more than 1hours and 30 minutes) had resolved and MULTIPLE SCLEROSIS (like a MS symptoms/ bad MS attack), URINARY TRACT INFECTION (in the hospital they discover they have a urine infection), FALL (felt 5 times in two weeks/End it up in the Emergency room with a concussion from falling out from  a electric wheel chair,), ASTHENIA (was so week, so spatial disoriented/was so weak and didn't fall flat on their back/became very weak, and went to lay down), FEELING ABNORMAL (did not felt good/ bad falling /first episode was within 48 hours after getting the vaccine,), VISUAL IMPAIRMENT (couldn't see clearly/was like having oil in their eyes/eyes balance and been weak.), VISION BLURRED (was very blurry/ vision was so bad that kept running into walls), FEEDING DISORDER (couldn't eat anything), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't cook) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication included antidepressant and water pills. The patient never had COVID or COVID test or diagnosis. The patient stated that they are calling regarding a probable a overreaction to the Moderna full vaccine as a booster.  The patient stated that they got the first and second dose with Pfizer and waited 7 months to get the. Moderna booster but received a full dose on the 13Jan22 with lot number 018f21a. She stated that she felt 5 times in two weeks, and did not have any flu like symptoms, but did not felt good, and on the 15Jan2022 was trying to get up a half a foot from the wheal chair, and was so weak and did not fall flat on their back and put herself up and knew they have to rest, and went to the kitchen to get something to eat and became very weak, and went to lay down. Also they stated that the first episode was within 48 hours after getting the vaccine, weakness, could not see clearly, was like having oil in their eyes. The patient felt form their wheel chair and was unconscious for more than 1hours and 30 minutes, and had to call the ambulance, and in the hospital they discover they have a urine infection. They also stated that all the time was very weak and could not eat anything, and could not cook, and kept getting weak for two weeks. No treatment medication provided. Company comment: This is a spontaneous case concerning a 71-year-old female patient with medical history of Multiple sclerosis attack 7 years ago and wheelchair user due to spinal cord injury, who experienced the events loss of consciousness, MS-like syndrome and urinary tract infection, after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous primary  vaccination with Comirnaty). Patient started having weakness, vision blurred and feeling abnormal, described as MS-like symptoms, 48 hours after vaccination. She stated had falls 5 times after vaccination, the most relevant 16 days after vaccination with concussion and loss of consciousness of approximately 90 minutes that leads to seek for medical attention. In the hospital a UTI was discovered.  Inappropriate schedule of product administration was also captured as an event. The medical history of MS remains a confounder for MS-like syndrome and spinal cord injury remains a confounder for events fall and urinary tract infection.  The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: Company comment: This is a spontaneous case concerning a 71-year-old female patient with medical history of Multiple sclerosis attack 7 years ago and wheelchair user due to spinal cord injury, who experienced the events loss of consciousness, MS-like syndrome and urinary tract infection, after receiving dose of mRNA-1273 (third dose of COVID-19 vaccine; previous primary  vaccination with Comirnaty). Patient started having weakness, vision blurred and feeling abnormal, described as MS-like symptoms, 48 hours after vaccination. She stated had falls 5 times after vaccination, the most relevant 16 days after vaccination with concussion and loss of consciousness of approximately 90 minutes that leads to seek for medical attention. In the hospital a UTI was discovered.  Inappropriate schedule of product administration was also captured as an event. The medical history of MS remains a confounder for MS-like syndrome and spinal cord injury remains a confounder for events fall and urinary tract infection.  The benefit-risk relationship of mRNA-1273 is not affected by this report.