Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Raynaud's phenomenon, Vaccination complication, Vaccination failure
Clinical narrative: ARM SUPER HEAVY; ARM HURTS; NONINFECTIVE ENCEPHALITIS; CENTRAL NERVOUS SYSTEM INFLAMMATION; ACUTE DISSEMINATED ENCEPHALOMYELITIS; COVID-19; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; BLOOD TEST NORMAL; COMPUTERISED TOMOGRAM HEAD NORMAL; OROPHARYNGEAL PLAQUE; VACCINATION COMPLICATION; LABORATORY TEST ABNORMAL; HYPOAESTHESIA; PARAESTHESIA; RAYNAUD'S DISEASE; FREAKING OUT; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 24-year-old female. The patient's height, and weight were not reported. The patient had no current illnesses, no past history and no allergies, completely healthy prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 23-AUG-2021) dose was not reported, one total administered on 09-MAR-2021 to left arm for an unspecified indication. Concomitant medications included vitamins nos. On 15-APR-2021, 3 weeks after after vaccination, patient found a white plaque under her tongue (Oropharyngeal plaque), loosing blood flow and then would go back to normal (Raynaud's disease). This symptom has just got a bit better just recently.  On APR-2021, She also felt sensitivity on fingers of the left hand which then spread to the right side and in toes as well, turning numb (hypoaesthesia), also reported vaccination complication, she started experiencing tingling which turned numb in arms and legs which started on the right side and spread to the left side and to the neck area, heavy (paraesthesia), On APR-2021, She started freaking out and her company sent her to visit a clinic in Mexico. They did blood work, CAT scan of the brain and X-ray of the spine (on April 20, 2021) and they could not find anything of note. On 20-APR-2021, the patient's blood test was normal, computerised tomogram of the head  was normal.  On 09-JUL-2021,the patient experienced symptoms of covid (nausea, loss of smell, very high fever, headache and fatigue) and was tested at a minute clinic and the result of the PCR test was positive for covid and this results in confirmed clinical vaccination failure. On AUG-2021, patient started experiencing cognitive issues, losing memory and lost focus. She was working from home for more than 2 weeks and went back to work but the lack of focus impacted her work. The tingling sensation became more frequent and felt like her arm was falling down (arm super heavy, and it hurts). In August, she travelled and saw a neurologist. The physician did a CT scan with contrast of the brain which showed she had inflammation in the brain that attacked her nervous system. A magnetic resonance imaging scan was performed which confirmed the diagnosis of ADEM (acute disseminated encephalomyelitis, central nervous system inflammation and non-infective encephalitis). On 01-SEP-2021, She did a course of IV corticosteroids for 5 days in the hospital and then came back to the United States to see the results towards the end of August and beginning of September and 01-OCT-2021, there were no signs of betterment started another treatment with corticosteroids an oral regimen of waning corticosteroid dose from 40mg to 5 mg during a period of 6 weeks. She has not observed any changes in the tingling and numbness of the arms and legs and the only thing is that the white plaque under her tongue has gotten better.  The patient was due to make another trip for further treatment.  Patient had also visited emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from oropharyngeal plaque, and Raynaud's disease, had not recovered from covid-19, central nervous system inflammation, hypoaesthesia, laboratory test abnormal, noninfective encephalitis, paraesthesia, vaccination complication, blood test normal, computerised tomogram head normal, sars-cov-2 test positive, arm super heavy, and arm hurts, and the outcome of confirmed clinical vaccination failure, freaking out and acute disseminated encephalomyelitis was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000198169, 90000203009 The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from patient on 18-NOV-2021 and via telephone communications log (TCL) on 22-NOV-2021 from the patient. The following information was updated and incorporated into the case narrative: Reporter (patient name, address, physician as contact), date of birth, patient initials, ethnicity, vaccine expiry date, new events (arm super heavy, and arm hurts, confirmed clinical vaccination failure, freaking out and acute disseminated encephalomyelitis, Raynaud's disease), onset date (onset date of the event covid-19, computerised tomogram head normal, sars-cov-2 test positive), outcome (recovering of event from oropharyngeal plaque), lab test date (sars-cov-2 test and computerised tomogram head), vaccine facility, product quality complaint number (90000203009), : Product quality complaint results added.; Sender's Comments: V2 : Follow adds new events, patient details, labs, and outcome of the event. This spontaneous report received from a patient via (VAERS concerned a 24-year-old  female who  experienced  acute disseminated encephalomyelitis and noninfective encephalitis that was confirmed by MRI,  approximately 5 months after vaccination. The patient had no concurrent illnesses or  past history . She was completely healthy prior to vaccination. Three weeks after  vaccination, patient developed an Oropharyngeal plaque and Raynaud's disease. She started experiencing tingling ,numbness tingling, numbness and paresthesia in arms , legs and in the neck area . All the labs and imaging results are were normal. The patient experienced symptoms of COVID and  PCR test was positive for  COVID , with confirmed clinical vaccination failure 122 days post vaccination.  A month later, patient started experiencing cognitive issues , memory loss and lack of focus . She consulted a neurologist. A CT scan with contrast .Treatment included  a course of IV corticosteroids for 5 days in the hospital. there There were no signs of improvement even after  2 months .months. She was started on an oral regimen of waning corticosteroid dose over period of 6 weeks without only improvement in the  oral plaque . At the time of the report, the patient was recovering from oropharyngeal plaque, and Raynaud's disease, had not recovered from  COVID infection. The outcome of the event disseminated encephalomyelitis was not reported. Considering the long temporal relationship and confounding recent COVID infection,  the causal association of the event to vaccination is assessed to be inconsistent.