Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Photophobia, Presyncope, SARS-CoV-2 test, Skin irritation
Clinical narrative: Diagnosed with ADEM/tingling in both arms, legs & hands/ unable to think straight/ sleeping less/ Left leg would stick out when  walked/ Numbness inside of mouth/ Tingling inside of mouth/ Double vision / double vision of words & objects; Anxiety; difficulty breathing; shortness of breath on exertion; pinching feeling in the top of scalp; Black floaters in right eye; Excruciating chest pain/had chest pain; difficulty with balance/ off balance; Weakness of leg/I had a lack of energy; pain behind eyes; ear pain; Muscle weakness; Numbness in both arms, legs & hands/Numbness in legs; Tiredness/fatigue; neck pain/Soreness & pain in neck/pain in my neck; Difficulty with standing for long periods of time/could stand for only 5-6 minutes; loss of appetite; Drainage in throat; Pressure in throat; Dizziness; Ear infection/Ears felt like they had liquid in them/Ear pressure/still having issues with ears/inflammation in ears / inflammation in both ears; Head was spinning; Had the sensation of passing out/ felt like I was going to pass out; Head pressure/ Feeling a lot of pressure in my head; Eyes were sensitive to light/had vision changes in the form of sensitivity to light, & saw halos/had sensitivity to brighter lights, like lightbulbs, & I saw streaks; Head pain; Nausea/ had a strong sense of smell to the point of nausea; Arm was really stiff; Arm was really sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (Diagnosed with ADEM/tingling in both arms, legs & hands/ unable to think straight/ sleeping less/ Left leg would stick out when  walked/ Numbness inside of mouth/ Tingling inside of mouth/ Double vision / double vision of words & objects), VERTIGO (Head was spinning), VITREOUS FLOATERS (Black floaters in right eye), DECREASED APPETITE (loss of appetite), INCREASED UPPER AIRWAY SECRETION (Drainage in throat), THROAT TIGHTNESS (Pressure in throat), DIZZINESS (Dizziness), EAR INFECTION (Ear infection/Ears felt like they had liquid in them/Ear pressure/still having issues with ears/inflammation in ears / inflammation in both ears), EYE PAIN (pain behind eyes), EAR PAIN (ear pain), MUSCULAR WEAKNESS (Muscle weakness), HYPOAESTHESIA (Numbness in both arms, legs & hands/Numbness in legs), SKIN IRRITATION (pinching feeling in the top of scalp), ANXIETY (Anxiety), ASTHENIA (Weakness of leg/I had a lack of energy), DYSPNOEA (difficulty breathing), NECK PAIN (neck pain/Soreness & pain in neck/pain in my neck), DYSSTASIA (Difficulty with standing for long periods of time/could stand for only 5-6 minutes), CHEST PAIN (Excruciating chest pain/had chest pain), BALANCE DISORDER (difficulty with balance/ off balance), PRESYNCOPE (Had the sensation of passing out/ felt like I was going to pass out), HEAD DISCOMFORT (Head pressure/ Feeling a lot of pressure in my head), PHOTOPHOBIA (Eyes were sensitive to light/had vision changes in the form of sensitivity to light, & saw halos/had sensitivity to brighter lights, like lightbulbs, & I saw streaks), HEADACHE (Head pain), NAUSEA (Nausea/ had a strong sense of smell to the point of nausea), FATIGUE (Tiredness/fatigue) and DYSPNOEA EXERTIONAL (shortness of breath on exertion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was really stiff) and VACCINATION SITE PAIN (Arm was really sore at the injection site). On 06-May-2021, the patient experienced VERTIGO (Head was spinning) (seriousness criterion medically significant), DECREASED APPETITE (loss of appetite) (seriousness criterion medically significant), INCREASED UPPER AIRWAY SECRETION (Drainage in throat) (seriousness criterion medically significant), THROAT TIGHTNESS (Pressure in throat) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), EAR INFECTION (Ear infection/Ears felt like they had liquid in them/Ear pressure/still having issues with ears/inflammation in ears / inflammation in both ears) (seriousness criterion medically significant), PRESYNCOPE (Had the sensation of passing out/ felt like I was going to pass out) (seriousness criterion medically significant), HEAD DISCOMFORT (Head pressure/ Feeling a lot of pressure in my head) (seriousness criterion medically significant), PHOTOPHOBIA (Eyes were sensitive to light/had vision changes in the form of sensitivity to light, & saw halos/had sensitivity to brighter lights, like lightbulbs, & I saw streaks) (seriousness criterion medically significant), HEADACHE (Head pain) (seriousness criterion medically significant) and NAUSEA (Nausea/ had a strong sense of smell to the point of nausea) (seriousness criterion medically significant). On 15-May-2021, the patient experienced EYE PAIN (pain behind eyes) (seriousness criterion medically significant), EAR PAIN (ear pain) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in both arms, legs & hands/Numbness in legs) (seriousness criterion medically significant), ASTHENIA (Weakness of leg/I had a lack of energy) (seriousness criterion medically significant), NECK PAIN (neck pain/Soreness & pain in neck/pain in my neck) (seriousness criterion medically significant), DYSSTASIA (Difficulty with standing for long periods of time/could stand for only 5-6 minutes) (seriousness criterion medically significant), BALANCE DISORDER (difficulty with balance/ off balance) (seriousness criterion medically significant) and FATIGUE (Tiredness/fatigue) (seriousness criterion medically significant). 15-May-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced CHEST PAIN (Excruciating chest pain/had chest pain) (seriousness criterion medically significant). On 12-Aug-2021, the patient experienced VITREOUS FLOATERS (Black floaters in right eye) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced SKIN IRRITATION (pinching feeling in the top of scalp) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced DYSPNOEA (difficulty breathing) (seriousness criterion medically significant) and DYSPNOEA EXERTIONAL (shortness of breath on exertion) (seriousness criterion medically significant). On 29-Sep-2021, the patient experienced ANXIETY (Anxiety) (seriousness criterion medically significant). On 05-Oct-2021, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (Diagnosed with ADEM/tingling in both arms, legs & hands/ unable to think straight/ sleeping less/ Left leg would stick out when  walked/ Numbness inside of mouth/ Tingling inside of mouth/ Double vision / double vision of words & objects) (seriousness criterion medically significant). The patient was treated with PREDNISONE on 25-Aug-2021 at a dose of 20 mg x9days in a titrating dose schedule; PREDNISONE ongoing from 05-Oct-2021 at a dose of 10 mg x 16 days; AMOXICILLIN ongoing from 06-May-2021 for Ear infection, at an unspecified dose and frequency; MECLIZINE [MECLOZINE] ongoing from 15-May-2021 for Dizziness, at a dose of 25 mg three times a day; METHYLPREDNISOLONE ongoing from 11-Jun-2021 for Ear inflammation, at a dose of 4 mg xx7 days in a titrating dose; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) ongoing from 11-Jun-2021 for Ear inflammation, at a dose of UNK UNK, bid; METHOCARBAMOL ongoing from 19-Jun-2021 for Neck pain, at a dose of 750 mg 2 tabs 4 times daily; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from 19-Jun-2021 for Headache and Neck pain, at an unspecified dose and frequency; NAPROXEN ongoing from 01-Jul-2021 for Ear inflammation, at a dose of 500 mg twice a day; CYCLOBENZAPRINE ongoing from 01-Jul-2021 for Ear inflammation, at a dose of 5 mg once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 01-Jul-2021 for Ear inflammation, at a dose of UNK UNK, qd; ALBUTEROL [SALBUTAMOL] ongoing from 19-Sep-2021 for Shortness of breath, at a dose of 90 mcg 2 puffs every 4 hours; SERTRALINE HCL ongoing from 29-Sep-2021 for Anxiety, at a dose of 50 mg and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]) ongoing from 15-May-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (Diagnosed with ADEM/tingling in both arms, legs & hands/ unable to think straight/ sleeping less/ Left leg would stick out when  walked/ Numbness inside of mouth/ Tingling inside of mouth/ Double vision / double vision of words & objects), VERTIGO (Head was spinning), VITREOUS FLOATERS (Black floaters in right eye), DECREASED APPETITE (loss of appetite), INCREASED UPPER AIRWAY SECRETION (Drainage in throat), THROAT TIGHTNESS (Pressure in throat), DIZZINESS (Dizziness), EAR INFECTION (Ear infection/Ears felt like they had liquid in them/Ear pressure/still having issues with ears/inflammation in ears / inflammation in both ears), EYE PAIN (pain behind eyes), EAR PAIN (ear pain), MUSCULAR WEAKNESS (Muscle weakness), HYPOAESTHESIA (Numbness in both arms, legs & hands/Numbness in legs), SKIN IRRITATION (pinching feeling in the top of scalp), ANXIETY (Anxiety), ASTHENIA (Weakness of leg/I had a lack of energy), HEADACHE (Head pain), DYSPNOEA EXERTIONAL (shortness of breath on exertion), MUSCULOSKELETAL STIFFNESS (Arm was really stiff) and VACCINATION SITE PAIN (Arm was really sore at the injection site) outcome was unknown and DYSPNOEA (difficulty breathing), NECK PAIN (neck pain/Soreness & pain in neck/pain in my neck), DYSSTASIA (Difficulty with standing for long periods of time/could stand for only 5-6 minutes), CHEST PAIN (Excruciating chest pain/had chest pain), BALANCE DISORDER (difficulty with balance/ off balance), PRESYNCOPE (Had the sensation of passing out/ felt like I was going to pass out), HEAD DISCOMFORT (Head pressure/ Feeling a lot of pressure in my head), PHOTOPHOBIA (Eyes were sensitive to light/had vision changes in the form of sensitivity to light, & saw halos/had sensitivity to brighter lights, like lightbulbs, & I saw streaks), NAUSEA (Nausea/ had a strong sense of smell to the point of nausea) and FATIGUE (Tiredness/fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Computerised tomogram head: normal (normal) normal. On 19-Jun-2021, X-ray: normal (normal) normal. On 07-Sep-2021, Chest X-ray: normal (normal) normal. On 07-Sep-2021, Echocardiogram: normal (normal) normal. On 07-Sep-2021, Oxygen saturation: normal (normal) normal. On 19-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications provided. On 10 May 2021 patient got prescription for glasses. On 15 May 2021 patient had ear pressure. The doctor felt like it was an allergy. On 11 Jun 2021 patient saw an ENT doctor and was still having issues with ears. He noticed inflammation in my ears. On 19 Jun 2021 went to the emergency room, because patient was feeling a lot of pressure in her head, soreness and pain in her neck. On 01Jul 2021, patient felt chest pain, but doctor said it might be muscular pain. On 5 Aug 21, made a follow up visit with PCP and said feeling better. Patient did a magnetic resonance imaging scan on 29 Sep 2021 but result were not provided. On 05 Oct 21, PCP started intravenous steroid for acute disseminated encephalomyelitis, treatment was from 05 Oct 2021 to 08 Oct 2021 once daily. After intravenous treatment, neurologist prescribed oral steroids. Patient was prescribed with ondansetron 4mg but patient never not took it. Patient also had some future appointments for second magnetic resonance imaging scan on 23 Nov 2021, follow up visit with neurologist on 30 Nov 2021 and on 03 Dec 2021, and another neurology for second opinion on treatment. Company Comment: This case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of musculoskeletal stiffness , vaccination site pain, vertigo, decreased appetite, increased upper airway secretion, throat tightness, dizziness, ear infection, presyncope, head discomfort, photophobia, headache , nausea, eye pain, ear pain, hypoaesthesia, asthenia, neck pain, dysstasia, balance disorder, fatigue, muscular weakness, chest pain, vitreous floaters, skin irritation, dyspnoea, dyspnoea exertional, anxiety and the unexpected serious AESI event of acute disseminated encephalomyelitis. The events musculoskeletal stiffness and vaccination site pain occurred approximately on the same day after the second dose of Moderna COVID-19 vaccine, the events vertigo   This case was linked to MOD-2021-373620 (Patient Link).; Sender's Comments: This case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of musculoskeletal stiffness , vaccination site pain, vertigo, decreased appetite, increased upper airway secretion, throat tightness, dizziness, ear infection, presyncope, head discomfort, photophobia, headache , nausea, eye pain, ear pain, hypoaesthesia, asthenia, neck pain, dysstasia, balance disorder, fatigue, muscular weakness, chest pain, vitreous floaters, skin irritation, dyspnoea, dyspnoea exertional, anxiety and the unexpected serious AESI event of acute disseminated encephalomyelitis. The events musculoskeletal stiffness and vaccination site pain occurred approximately on the same day after the second dose of Moderna COVID-19 vaccine, the events vertigo, decreased appetite, increased upper airway secretion, throat tightness, dizziness, ear infection, presyncope, head discomfort, photophobia, headache , nausea, eye pain, ear pain, hypoaesthesia, asthenia, neck pain, dysstasia, balance disorder, fatigue, muscular weakness, during the following month of the same dose, the rest of the events appeared between two to four months after vaccination, with the confirmation diagnosis of acute disseminated encephalomyelitis 5 months after the second dose of the vaccine. The rechallenge was not applicable since the events were ongoing at the time of the report. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Case was assessed as serious due to important medical event and medical judgement.