Age: 47.0
Sex: F
Vaccine: COVID19, DTAP, FLUX
Symptoms: Computerised tomogram, Confusional state, Eye pain, Headache, Illness
Clinical narrative: She got sick with the congestion; Sickness; Throat clearing; Neurological disorder nos; Eye pain; Confussion; experiencing Sore throat; Shakiness; Multiple sclerosis relapse; Headache; Twitches of the face; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) in a 47-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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Vaccination and INFLUENZA VACCINE (FLU VACCINE VII) for Vaccination.    The patient's past medical history included Tobacco user and Knee replacement. Concurrent medical conditions included Memory impairment and Multiple sclerosis. Concomitant products included NICOTINE (NICOTINE TRANSDERMAL SYSTEM) for Cessation of smoking, TERIFLUNOMIDE from 11-Feb-2018 to an unknown date for Multiple sclerosis, BUPROPION, VITAMIN D3, DULOXETINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), CELECOXIB (CELEBREX) and TIZANIDINE for an unknown indication.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 25-May-2020, the patient experienced MUSCLE TWITCHING (Twitches of the face). On 17-Apr-2021, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) (seriousness criterion medically significant) and HEADACHE (Headache). On an unknown date, the patient experienced TREMOR (Shakiness), NASAL CONGESTION (She got sick with the congestion), ILLNESS (Sickness), THROAT CLEARING (Throat clearing), NERVOUS SYSTEM DISORDER (Neurological disorder nos), EYE PAIN (Eye pain), CONFUSIONAL STATE (Confussion) and OROPHARYNGEAL PAIN (experiencing Sore throat). The patient was treated with LORAZEPAM (ATIVAN) ongoing since an unknown date for Palpitation, Extrasystoles and Chest pain, at a dose of UNK dosage form; BIOTIN ongoing since an unknown date for Hair thinning, at an unspecified dose and frequency; TOPIRAMATE for Migraine, at a dose of 75 mg and BOTULINUM TOXIN TYPE A (BOTOX) at a dose of UNK dosage form. At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse), TREMOR (Shakiness), MUSCLE TWITCHING (Twitches of the face), NASAL CONGESTION (She got sick with the congestion), ILLNESS (Sickness), THROAT CLEARING (Throat clearing), NERVOUS SYSTEM DISORDER (Neurological disorder nos), EYE PAIN (Eye pain), CONFUSIONAL STATE (Confussion), OROPHARYNGEAL PAIN (experiencing Sore throat) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Computerised tomogram: pelvis abnormal (abnormal) pelvis abnormal.. On 15-Jun-2020, Weight: decreased (Low) 116 pounds.. In July 2020, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19..         Treatment included that the patient had taking topiramate half a tablet in the morning, whole tablet in the evening and increased the dose in Jun-2021.  The  patient called her neurologist because she had issues with her eyes. Her neurologist told her to call the eye doctor. She went on 30-Jun-2021 and had lots of testing and was told there's nothing wrong with her eyes, but it has a neurological problem, the optometrist said she had still in a relapse and feels it's due to the COVID vaccine.  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. The patient's medical history of multiple sclerosis is a possible confounding factor.; 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. The patient's medical history of multiple sclerosis is a possible confounding factor.