Age: 64.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Product dose omission issue, Sepsis, Social anxiety disorder, Underdose, Urinary incontinence
Clinical narrative: increased fatigue with exercise and being out in the sun; memory is shot, memory problems; trouble with sleep at times; double vision episode, had some double vision; bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water; big crowds cause her stress; wording is getting worse; worsening bladder control; drunken walk, she was like walking in like she's drunk, and running into the door way; steroids gave him black sticky diarrhea; speech has been slurred; dry mouth; nurse was not able to clarify some cognitive issue; severe cold/ bad cold; she was hospitalized for a blood infection; filed for disability worsening of her MS; bruising; hair loss or bald spots/hair thinning; feel the burning in both feet; numbness on bottom of both feet; steroids gave him black sticky diarrhea; balance disorder; had a lapse on therapy, was out of medicine for about a week; dizziness; felt like a train ran over her; underdose of the medications; had an ulcer in her stomach, which was new to her and bleeding also; started breaking the medication in half/ has been braking 14mg in half to make it last longer; had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder), GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also), SEPSIS (she was hospitalized for a blood infection), MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), INSOMNIA (trouble with sleep at times), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), NASOPHARYNGITIS (severe cold/ bad cold), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), ALOPECIA (hair loss or bald spots/hair thinning), BURNING SENSATION (feel the burning in both feet), HYPOAESTHESIA (numbness on bottom of both feet), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TERIFLUNOMIDE for an unknown indication, BUPROPION HCL for an unknown indication and WARFARIN SODIUM (COUMADIN) for an unknown indication.    The patient's past medical history included Rheumatic fever, Application site reaction, Diplopia and Cardiac valve prosthesis user in 2007. Concurrent medical conditions included Allergy to animal, Drug hypersensitivity (Triple antibiotic), Iodine allergy (Iodine dye), Polyuria, Dermatitis contact, Drug hypersensitivity (Dilantin) and Multiple sclerosis. Concomitant products included LEVOTHYROXINE, IRON, METOPROLOL, FUROSEMIDE, PRAVASTATIN, WARFARIN SODIUM (JANTOVEN), VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) and SERTRALINE for an unknown indication.   On 15-May-2014, the patient started TERIFLUNOMIDE (unknown route) 14 milligram once a day. On 14-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, BUPROPION HCL (unknown route) 1 dosage form and WARFARIN SODIUM (COUMADIN) (unknown route) at an unspecified dose. In March 2015, the patient experienced PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and) (seriousness criteria hospitalization prolonged and disability). In January 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) (seriousness criteria hospitalization prolonged and disability). On 14-Feb-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) (seriousness criteria hospitalization prolonged, disability and medically significant). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a train ran over her) (seriousness criteria hospitalization prolonged and disability). 14-Mar-2021, the patient experienced UNDERDOSE (underdose of the medications). In May 2021, the patient experienced DIZZINESS (dizziness) (seriousness criteria hospitalization prolonged and disability) and PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) (seriousness criteria hospitalization prolonged and disability). On 19-Jun-2021, the patient experienced BALANCE DISORDER (balance disorder) (seriousness criteria hospitalization prolonged and disability). On an unknown date, the patient experienced SEPSIS (she was hospitalized for a blood infection) (seriousness criteria hospitalization prolonged, disability and medically significant), MULTIPLE SCLEROSIS (filed for disability worsening of her MS) (seriousness criteria hospitalization prolonged, disability and medically significant), CONTUSION (bruising) (seriousness criteria hospitalization prolonged and disability), FATIGUE (increased fatigue with exercise and being out in the sun) (seriousness criteria hospitalization prolonged and disability), MEMORY IMPAIRMENT (memory is shot, memory problems) (seriousness criteria hospitalization prolonged and disability), INSOMNIA (trouble with sleep at times) (seriousness criteria hospitalization prolonged and disability), DIPLOPIA (double vision episode, had some double vision) (seriousness criteria hospitalization prolonged and disability), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water) (seriousness criteria hospitalization prolonged and disability), SOCIAL ANXIETY DISORDER (big crowds cause her stress) (seriousness criteria hospitalization prolonged and disability), APHASIA (wording is getting worse) (seriousness criteria hospitalization prolonged and disability), URINARY INCONTINENCE (worsening bladder control) (seriousness criteria hospitalization prolonged and disability), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way) (seriousness criteria hospitalization prolonged and disability), FAECES DISCOLOURED (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant), DYSARTHRIA (speech has been slurred) (seriousness criteria hospitalization prolonged and disability), DRY MOUTH (dry mouth) (seriousness criteria hospitalization prolonged and disability), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue) (seriousness criteria hospitalization prolonged, disability and medically significant), NASOPHARYNGITIS (severe cold/ bad cold) (seriousness criteria hospitalization prolonged and disability), ALOPECIA (hair loss or bald spots/hair thinning) (seriousness criteria hospitalization prolonged and disability), BURNING SENSATION (feel the burning in both feet) (seriousness criteria hospitalization prolonged and disability), HYPOAESTHESIA (numbness on bottom of both feet) (seriousness criteria hospitalization prolonged and disability) and DIARRHOEA (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was treated with OXYBUTYNIN ongoing since an unknown date for Urinary incontinence, at a dose of 1 dosage form; PARACETAMOL ongoing since an unknown date for Insomnia, at a dose of 1 dosage form; DIPHENHYDRAMINE ongoing since an unknown date for Insomnia, at a dose of 1 dosage form and BENZOCAINE ongoing since an unknown date for Hypoaesthesia and Burning sensation, at a dose of 1 dosage form. On 23-Feb-2021, GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) had resolved. At the time of the report, FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder) and SEPSIS (she was hospitalized for a blood infection) had resolved, MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), NASOPHARYNGITIS (severe cold/ bad cold), ALOPECIA (hair loss or bald spots/hair thinning), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) and UNDERDOSE (underdose of the medications) outcome was unknown and INSOMNIA (trouble with sleep at times), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), BURNING SENSATION (feel the burning in both feet) and HYPOAESTHESIA (numbness on bottom of both feet) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: low (Low) Low. On an unknown date, International normalised ratio: 6.28 (Inconclusive) 6.28.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.