Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Nausea, Oropharyngeal discomfort, Pain in extremity, Product dose omission issue
Clinical narrative: multiple sclerosis getting worse and having a MRI (magnetic resonance imaging) inJan-2017 where had more lesions in spine'; multiple allergy; left leg pain; stretching the medication characterized as unknown if she takes it every other day or every three days; missed dose of aubagio; congestion; breaking her finger; falling down the stairs/another fall (recurrent); vomiting; nasty flu; nauseas; spinal cord injury (due to another fall); problems with spatial recognition characterized by being unable to recognize where her hands and feet are; hurting her knee; new problem with high blood pressure; hair growth is stunted; hair growth is stunted; feeling that came up in her throat like a mist from an inhaler; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL CORD INJURY (spinal cord injury (due to another fall)) and MULTIPLE SCLEROSIS (multiple sclerosis getting worse and having a MRI (magnetic resonance imaging) inJan-2017 where had more lesions in spine') in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE coated tablet for Multiple sclerosis.    The patient's past medical history included Illness, Hypoaesthesia, Burning sensation, Headache and Hospitalisation (Unspecified reason) in January 2017. Previously administered products included for Drug use for unknown indication: INTERFERON BETA-1A. Past adverse reactions to the above products included No adverse event with INTERFERON BETA-1A. Concurrent medical conditions included Mental disorder, Stress, Alopecia, Weight decreased, Suicidal ideation, Balance disorder, Bipolar disorder, Seasonal allergy (spring allergies), Drug allergy (The patient had multiple allergies including sulfa, codeine, Cymbalta (duloxetine), Lyrica (pregabalin), penicillin, morphine, band-aids and coating.), Multiple sclerosis aggravated, Depression since March 2017, Mania since March 2017 and Memory impairment since March 2017. Concomitant products included OXCARBAZEPINE (TRILEPTAL) and ARIPIPRAZOLE from 04-Mar-2020 to an unknown date for Bipolar disorder, RISPERIDONE for Mood alteration NOS, ESTRADIOL, NALTREXONE, OMEPRAZOLE, LEVOTHYROXINE, ESTROGENS CONJUGATED and MELOXICAM for an unknown indication.   On 24-Mar-2017, the patient started TERIFLUNOMIDE (Oral) 14 milligram once a day. In 2017, TERIFLUNOMIDE (Oral) dosage was changed to 14 milligram once a day. On 21-Apr-2021, TERIFLUNOMIDE (Oral) dosage was changed to 14 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2017, the patient experienced HYPERTENSION (new problem with high blood pressure). In 2017, the patient experienced OROPHARYNGEAL DISCOMFORT (feeling that came up in her throat like a mist from an inhaler), the first episode of HAIR GROWTH ABNORMAL (hair growth is stunted) and the second episode of HAIR GROWTH ABNORMAL (hair growth is stunted). In 2018, the patient experienced JOINT INJURY (hurting her knee). On 19-Apr-2019, the patient experienced NAUSEA (nauseas). On 20-Apr-2019, the patient experienced INFLUENZA (nasty flu). On 20-Apr-2019 at 2:00 AM, the patient experienced VOMITING (vomiting). In May 2019, the patient experienced FALL (falling down the stairs/another fall (recurrent)) and LIMB INJURY (breaking her finger). In 2019, the patient experienced SPINAL CORD INJURY (spinal cord injury (due to another fall)) (seriousness criterion medically significant) and DISORIENTATION (problems with spatial recognition characterized by being unable to recognize where her hands and feet are). In 2021, the patient experienced RESPIRATORY TRACT CONGESTION (congestion). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis getting worse and having a MRI (magnetic resonance imaging) inJan-2017 where had more lesions in spine') (seriousness criterion medically significant), MULTIPLE ALLERGIES (multiple allergy), PAIN IN EXTREMITY (left leg pain), PRODUCT USE ISSUE (stretching the medication characterized as unknown if she takes it every other day or every three days) and PRODUCT DOSE OMISSION ISSUE (missed dose of aubagio). The patient was treated with LEVOCETIRIZINE for Congestion nasal, at an unspecified dose and frequency; AMLODIPINE on 29-Jun-2021 for Blood pressure high, at an unspecified dose and frequency; TIZANIDINE HYDROCHLORIDE (ZANAFLEX) at an unspecified dose and frequency and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) at an unspecified dose and frequency. At the time of the report, SPINAL CORD INJURY (spinal cord injury (due to another fall)), FALL (falling down the stairs/another fall (recurrent)), MULTIPLE ALLERGIES (multiple allergy), DISORIENTATION (problems with spatial recognition characterized by being unable to recognize where her hands and feet are), RESPIRATORY TRACT CONGESTION (congestion), PAIN IN EXTREMITY (left leg pain), NAUSEA (nauseas) and VOMITING (vomiting) had not resolved, MULTIPLE SCLEROSIS (multiple sclerosis getting worse and having a MRI (magnetic resonance imaging) inJan-2017 where had more lesions in spine'), the last episode of HAIR GROWTH ABNORMAL (hair growth is stunted), INFLUENZA (nasty flu), HYPERTENSION (new problem with high blood pressure), PRODUCT USE ISSUE (stretching the medication characterized as unknown if she takes it every other day or every three days) and PRODUCT DOSE OMISSION ISSUE (missed dose of aubagio) outcome was unknown and OROPHARYNGEAL DISCOMFORT (feeling that came up in her throat like a mist from an inhaler), JOINT INJURY (hurting her knee) and LIMB INJURY (breaking her finger) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2017, Magnetic resonance imaging: More lesions in spine. On an unknown date, Blood pressure measurement: high blood pressure (mmHg). On an unknown date, Ultrasound scan: (Negative) Negative.         Reportedly, patient stated noticing no improvement with her balance issues since starting Aubagio and believed the spinal cord injury and lesions on her spinal cord are likely the cause of her balance issues and her spatial recognition issues. Reportedly that patient has been on and off allergies for the past 3 years especially when there is mold on the leaves and on the springtime. Nurse also mentioned that during the routine appointment, the doctor gave her something for the cough that is not covered under insurance. On 27-Mar-2020, consumer stopped taking Trileptal (oxcarbazepine). Treatment includes starting Aripiprazole 10 mg daily on 03-Apr-2020. Approximately one year ago, 01-Mar-2020, the patient stopped teriflunomide due to no funding and reported that her hair was still not growing, she has a bald spot and her hair growth was stunted (Hair growth abnormal; unknown onset and latency) which was new after she started on teriflunomide.  Events Spinal cord disorder(lesions on her spinal cord),  Micturition urgency (bladder urgency), Dyskinesia (jerky motions) , Dysphemia (stuttering), Grip strength decreased (causes things to be dropped), Sensory loss (loss of feeling), Feeling abnormal (Weird feeling), Muscle spasms (leg cramp), Dysphagia (trouble swallowing), Dizziness, Paraesthesia and Hypoaesthesia (spider web tingling and numbness) were reported symptoms of Multiple sclerosis.   Cough aggravated  (cough worsened), Throat irritation (tickle on the throat) were reported symptoms of Influenza  The reporter assessed event intervertebral disc lesions/disorientation as not related and did not provide causality assessment for rest of the events.  The patient had unspecified treatment for having some trouble swallowing and some weird symptoms.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient aged 56 years with relevant medical history of multiple sclerosis on TERIFLUNOMIDE reported, who experienced the unexpected serious (medically significant) events of Multiple sclerosis (Multiple sclerosis Aggravated) (AESI) and Spinal cord injury (spinal cord injury (due to another fall) in the context of mRNA-1273 vaccine. Patient had received two doses of mRNA-1273 on unknown dates hence Latency cannot be assessed. The events occurred on unknown dates in 2019 and not resolved. Patient also experienced multiple non serious events of multiple allergies, fall, influenza, hair growth abnormal. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Relevant medical history remains a confounder to the event Multiple sclerosis Aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 56 years with relevant medical history of multiple sclerosis on TERIFLUNOMIDE reported, who experienced the unexpected serious (medically significant) events of Multiple sclerosis (Multiple sclerosis Aggravated) (AESI) and Spinal cord injury (spinal cord injury (due to another fall) in the context of mRNA-1273 vaccine. Patient had received two doses of mRNA-1273 on unknown dates hence Latency cannot be assessed. The events occurred on unknown dates in 2019 and not resolved. Patient also experienced multiple non serious events of multiple allergies, fall, influenza, hair growth abnormal. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Relevant medical history remains a confounder to the event Multiple sclerosis Aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.