Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Coagulation factor V level, Coagulation test, Computerised tomogram head
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of OPTIC NEURITIS (Optic neuritis), ASTHENIA (severe weakness) and DYSPNOEA (dyspnoea) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     The patient's past medical history included Controlled hypertension (treated with amlodipine for one year). Concomitant products included AMLODIPINE for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced OPTIC NEURITIS (Optic neuritis) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced ASTHENIA (severe weakness) (seriousness criterion hospitalization), DYSPNOEA (dyspnoea) (seriousness criterion hospitalization) and FATIGUE (fatigue). The patient was treated with METHYLPREDNISOLONE for Optic neuritis, at a dose of 1000 milligram once a day; PREDNISONE for Optic neuritis, at a dose of 60 milligram once a day and PREDNISONE for Optic neuritis, at a dose of Taper dose. At the time of the report, OPTIC NEURITIS (Optic neuritis) had resolved and ASTHENIA (severe weakness), DYSPNOEA (dyspnoea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: (Negative) Negative. On an unknown date, Antimicrobial susceptibility test: (Negative) Negative. On an unknown date, Antineutrophil cytoplasmic antibody: (Negative) Negative, (Negative) Negative on outpatient follow-up appointment, (Negative) Negative and (Negative) Negative on outpatient follow-up appointment. On an unknown date, Antinuclear antibody: (Negative) Negative and (Negative) Negative on outpatient follow-up appointment. On an unknown date, Antiphospholipid antibodies: (Negative) Negative and (Negative) Negative. On an unknown date, Antithrombin III: (Negative) Negative. On an unknown date, Bartonella test: (Negative) Negative. On an unknown date, Blood folate: Normal. On an unknown date, Blood homocysteine: (Negative) Negative. On an unknown date, Blood thyroid stimulating hormone: Normal. On an unknown date, C-reactive protein: Normal. On an unknown date, Coagulation factor V level: (Negative) Negative. On an unknown date, Coagulation test: Normal. On an unknown date, Computerised tomogram head: (Negative) Negative. On an unknown date, Computerised tomogram thorax: (Negative) Negative for pulmonary embolism. On an unknown date, Echocardiogram: showed a normal ejection fraction with mild pulmonary hypertension with systolic pulmonary artery pressure of 45 mmHg. On an unknown date, Electrocardiogram: Normal. On an unknown date, Electrophoresis protein: (Negative) Negative. On an unknown date, Fibrin D dimer: Normal. On an unknown date, Full blood count: Normal. On an unknown date, Fundoscopy: showed trace nuclear sclerosis of the lens. The vitreous was clear bilaterally and no macular abnormalities were noted. No evidence of retinal detachment was noted. Vessels were normal with no signs of intraretinal hemorrhage. The optic nerve showed a cup-to-disk ratio of 0.3. There was no pallor of the optic nerve and no evidence of papilledema bilaterally. On an unknown date, HIV test: (Negative) Negative. On an unknown date, Hepatitis viral test: (Negative) Negative. On an unknown date, Intraocular pressure test: Anterior segment examination was unremarkable with intraocular pressure by Tono-pen of 15 in the right and 16 in the left eye. On an unknown date, Magnetic resonance imaging: Normal. On an unknown date, Magnetic resonance imaging head: Normal. On an unknown date, Magnetic resonance imaging neck: Normal. On an unknown date, Metabolic function test: Normal. On an unknown date, Ophthalmological examination: Revealed normal external examination with no signs of ptosis. Conjunctiva and sclera were normal. corneas were clear and transparent. periorbital area was normal. Extraocular muscle movements were intact bilaterally without pain in any direction. A left afferent pupillary defect (APD) was noted. The pupils were 2 mm round and reactive with positive APD in the left eye and normal eye and normal vision on outpatient follow-up appointment. On an unknown date, Protein C: (Negative) Negative. On an unknown date, Protein S: (Negative) Negative. On an unknown date, Red blood cell sedimentation rate: Normal. On an unknown date, Rheumatoid factor: (Negative) Negative and (Negative) Negative on outpatient follow-up appointment. On an unknown date, SARS-CoV-2 antibody test: (Negative) Negative. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Visual acuity tests: Jaeger score of 1 (Snellen 20/25) in the right eye and a Jaeger score of 5 (Snellen 20/50) in the left eye. On an unknown date, Visual field tests: Normal. On an unknown date, Vitamin B12: Normal.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered OPTIC NEURITIS (Optic neuritis), ASTHENIA (severe weakness), DYSPNOEA (dyspnoea) and FATIGUE (fatigue) to be related.    The patient presented to the hospital with impaired vision in left eye. Patient could not see letters on the computer with left eye due to blurred vision. Patient vision in the right eye was normal. The patient complained of discomfort in the left eyebrow and on the left side of the head. Patient reported shooting pain between the left ear and in the left eye. The patient noted a gritty sensation around left eye. Patient denied any fever, chills, dyspnea, or cough and did not complain of dizziness, diplopia or dysphagia. Patient had no focal neurodeficit or dysarthria. Patient was alert and oriented to place, time, and person. Patient complained of persistent fatigue since received the first dose of the Moderna vaccine eight days prior to the onset of visual symptoms. The patient had no prior history of impaired vision or autoimmune disorder.Patient reported remarkable improvement in her vision the following day. The pain in the left side of the face and head persisted, there were no signs of Bell's Palsy, but a clinical possibility of cranial nerve VII involvement was suspected. Patient was subsequently readmitted to the hospital one week later with new complaints of severe weakness and dyspnea. Patient fatigue was thought to be due to steroids but given the risks versus benefits of optic neuritis treatment, she was recommended to undergo the treatment dose as prescribed. Patient was recommended an MRI of the brain to evaluate for multiple sclerosis in six months.The patient was recommended against receiving the second dose of the mRNA COVID-19 vaccine.  This literature non -study case concerns a 47-year-old, female patient with medical history of well controlled hypertension, who experienced the unexpected serious(hospitalization and medically significant) AESI event of  Optic neuritis approximately 8 days after receiving the first dose of mRNA-1273 Vaccine in the covid-19 vaccination series. The patient presented to the hospital with impaired vision in her left eye, shooting pain between the left ear and in the left eye and gritty sensation around her left eye. Clinical examination and labs were non-significant and a diagnosis of optic neuritis was made. She was administered a high dose of methylprednisolone(1000mg) ,followed by prednisone 1 mg/kg (60 mg daily). She reported remarkable improvement in her vision the following day. The pain in the left side of the face and head persisted, no signs of Bell's Palsy, but a clinical possibility of cranial nerve VII involvement was suspected. She was subsequently readmitted to the hospital one week later with new complaints of severe weakness and dyspnea. Computed Tomography scan ruled out pulmonary embolism. The outcome of the event optic neuritis was recovered. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This literature non -study case concerns a 47-year-old, female patient with medical history of well controlled hypertension, who experienced the unexpected serious(hospitalization and medically significant) AESI event of  Optic neuritis approximately 8 days after receiving the first dose of mRNA-1273 Vaccine in the covid-19 vaccination series. The patient presented to the hospital with impaired vision in her left eye, shooting pain between the left ear and in the left eye and gritty sensation around her left eye. Clinical examination and labs were non-significant and a diagnosis of optic neuritis was made. She was administered a high dose of methylprednisolone(1000mg) ,followed by prednisone 1 mg/kg (60 mg daily). She reported remarkable improvement in her vision the following day. The pain in the left side of the face and head persisted, no signs of Bell's Palsy, but a clinical possibility of cranial nerve VII involvement was suspected. She was subsequently readmitted to the hospital one week later with new complaints of severe weakness and dyspnea. Computed Tomography scan ruled out pulmonary embolism. The outcome of the event optic neuritis was recovered. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.