Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin burning sensation, Tremor, Weight decreased
Clinical narrative: Lost weight; Nerve pain; increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,; Blood blisters (tiny all over body); Tip of tongue numb; Hand cramp - pinky finger on right hand turns inward painfully; Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling; Paralysis of arms and legs; Paralysis of arms and legs; Feeling abnormal; Neck Pain; Costochondritis; Loss of bladder control; Burning sensations, burning under skin; Muscle spasm; Twitching; Tremor; Stomach cramps; Weakness; Loss of appetite; Nausea; Joint pain; Headache; She had fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (Paralysis of arms and legs) and DIPLEGIA (Paralysis of arms and legs) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia supraventricular since 2008, Allergic reaction to antibiotics (sulfur antibiotics) and Penicillin allergy. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) from 11-Jan-2020 to 15-May-2021 for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (She had fatigue). On 12-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps), ASTHENIA (Weakness), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and HEADACHE (Headache). 12-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 16-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching) and TREMOR (Tremor). 16-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle spasm). 16-Mar-2021, the patient experienced SKIN BURNING SENSATION (Burning sensations, burning under skin). On 18-Mar-2021, the patient experienced INCONTINENCE (Loss of bladder control). On 29-Mar-2021, the patient experienced COSTOCHONDRITIS (Costochondritis). On 01-Apr-2021, the patient experienced MONOPLEGIA (Paralysis of arms and legs) (seriousness criterion medically significant) and DIPLEGIA (Paralysis of arms and legs) (seriousness criterion medically significant). 01-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and NECK PAIN (Neck Pain). On 02-Apr-2021, the patient experienced HYPOAESTHESIA (Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling). On 20-Apr-2021, the patient experienced MUSCLE SPASMS (Hand cramp - pinky finger on right hand turns inward painfully). On 21-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Tip of tongue numb). On 24-Apr-2021, the patient experienced BLOOD BLISTER (Blood blisters (tiny all over body)). On 01-May-2021, the patient experienced NEURALGIA (Nerve pain) and PAIN (increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,). On an unknown date, the patient experienced WEIGHT DECREASED (Lost weight). On 13-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, MONOPLEGIA (Paralysis of arms and legs), DIPLEGIA (Paralysis of arms and legs), FEELING ABNORMAL (Feeling abnormal) and NECK PAIN (Neck Pain) had resolved. On 22-Apr-2021, MUSCLE SPASMS (Hand cramp - pinky finger on right hand turns inward painfully) had not resolved, HYPOAESTHESIA ORAL (Tip of tongue numb) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps), MUSCLE TWITCHING (Twitching), TREMOR (Tremor), COSTOCHONDRITIS (Costochondritis), MUSCLE SPASMS (Muscle spasm), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), SKIN BURNING SENSATION (Burning sensations, burning under skin), INCONTINENCE (Loss of bladder control), HYPOAESTHESIA (Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling), BLOOD BLISTER (Blood blisters (tiny all over body)), NEURALGIA (Nerve pain), NAUSEA (Nausea), FATIGUE (She had fatigue) and ARTHRALGIA (Joint pain) had not resolved and WEIGHT DECREASED (Lost weight) and PAIN (increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced tremors and occasionally , experienced muscle spasms few times a day with different locations, weakness presented as an constant symptom, muscle twitchings  occurs daily but moving around, burning sensations appears during the tremors or after the tremors, joint pain worsening after tremors, the bladder and vaginal areas goes completely numb for an hour like an pinched nerves and happening after sitting on hard surface for 5 minutes , the patient could not able to walk or move for approx. 30 minutes when numbness presented. the patient experienced nerve pain which feels like hairs being plucked out and pain getting worse when bending the arm , neck part also feeling tingling and prickling type of pain. currently the patient experiencing the increased pain and vibrations all over the body ,burning, aching, pinching,  stinging, throbbing, numbness, tingling, and many more.   Treatment information was not reported/unknown.  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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient details received, stating that the reporter herself is the patient. On 21-May-2021: Follow-up received 21May2021. Additional adverse events were added from ADR form and attached patient symptom log and two events were upgraded to serious per IME list.; 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.