Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Heart rate, Hot flush, Inappropriate schedule of product administration
Clinical narrative: severe neuropathy in feet; Gait disruption,Couldn't walk more than 10 meters; Radiating sciatic, bilateral; Adrenaline rushes; Felt like an electric shot like pain; hot flashes; Major headaches level 7 pain; Full body tenderness; Flu like pain; tachycardia spiked to 130,tachycardia continues; Shortness of breath; large joint pain; severe mast cell reaction ( is a mast cell patient); Nausea; Fatigue; loss of appetite; lost 10 % of body weight; 2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea; Arm soreness/progressed into shooting leg pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe neuropathy in feet) and GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mast cell activation syndrome. Concurrent medical conditions included Drug allergy (Novocain (all cains)allergy), Drug allergy (Singulair allergy), Drug allergy (Cromolyn sodium allergy), Postural orthostatic tachycardia syndrome and Ehlers-Danlos syndrome. Concomitant products included IVABRADINE HYDROCHLORIDE (CORLANOR), RIVASTIGMINE (EXELON [RIVASTIGMINE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), KETOTIFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), NALTREXONE, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness/progressed into shooting leg pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea). On 14-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (lost 10 % of body weight), NAUSEA (Nausea) and FATIGUE (Fatigue). On 16-May-2021, the patient experienced MAST CELL ACTIVATION SYNDROME (severe mast cell reaction ( is a mast cell patient)). On 22-May-2021, the patient experienced ARTHRALGIA (large joint pain). On 26-May-2021, the patient experienced TACHYCARDIA (tachycardia spiked to 130,tachycardia continues) and DYSPNOEA (Shortness of breath). On 02-Jun-2021, the patient experienced TENDERNESS (Full body tenderness) and INFLUENZA LIKE ILLNESS (Flu like pain). On 08-Jun-2021, the patient experienced FEELING ABNORMAL (Adrenaline rushes), PAIN (Felt like an electric shot like pain), HOT FLUSH (hot flashes) and HEADACHE (Major headaches level 7 pain). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe neuropathy in feet) (seriousness criterion medically significant). an unknown date, the patient experienced GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) (seriousness criterion medically significant) and SCIATICA (Radiating sciatic, bilateral). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) (intravenous) on 08-Jun-2021 for Headache, at a dose of 30 mg; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Neuropathy, at an unspecified dose and frequency and GABAPENTIN for Neuropathy, at an unspecified dose and frequency. On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (severe neuropathy in feet), MAST CELL ACTIVATION SYNDROME (severe mast cell reaction ( is a mast cell patient)), DYSPNOEA (Shortness of breath), FEELING ABNORMAL (Adrenaline rushes), DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (lost 10 % of body weight), SCIATICA (Radiating sciatic, bilateral), TENDERNESS (Full body tenderness), INFLUENZA LIKE ILLNESS (Flu like pain), PAIN IN EXTREMITY (Arm soreness/progressed into shooting leg pain), PAIN (Felt like an electric shot like pain), HOT FLUSH (hot flashes), HEADACHE (Major headaches level 7 pain), ARTHRALGIA (large joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown and GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) and TACHYCARDIA (tachycardia spiked to 130,tachycardia continues) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Heart rate: 130 (High) tachycardia spiked to 130.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Medical history also included Mast cell reaction, allergies to slurines and ADD medicines.  Treatment also included IV medicines and topical pain cream.  Company Comment  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   This case was linked to MOD-2021-256724 (Patient Link).; 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.