Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Neurological symptom, Pain of skin, Tongue paralysis
Clinical narrative: cranial nerve deficit  4, 6,9, 10, 11, 12; tongue deviation to right; double vision; tongue biting; difficulty swallowing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CRANIAL NERVE PALSIES MULTIPLE (cranial nerve deficit  4, 6,9, 10, 11, 12) and TONGUE PARALYSIS (tongue deviation to right) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 021L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), OMEPRAZOLE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and COENZYME Q10 [UBIDECARENONE] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced deficit in the cranial nerves 4, 6, 9, 10, 11,12 after been vaccinated with 1st dose of Moderna Vaccine and difficulty with mouth which resulted in him biting his tongue. The patient's tongue deviates to the right, double vision, difficulty swallowing (swallow test was negative). Physical Exam, CTA to rule dissection (result was negative), Stroke tests were negative. MRI with/without contrast of the brain & upper spinal cord which was conducted twice and the results were normal. the patient is undergoing a neurophysiology count (result is pending)  The patient experienced CRANIAL NERVE PALSIES MULTIPLE (cranial nerve deficit  4, 6,9, 10, 11, 12) (seriousness criterion medically significant), TONGUE PARALYSIS (tongue deviation to right) (seriousness criterion medically significant), DIPLOPIA (double vision), TONGUE BITING (tongue biting) and DYSPHAGIA (difficulty swallowing). At the time of the report, CRANIAL NERVE PALSIES MULTIPLE (cranial nerve deficit  4, 6,9, 10, 11, 12), TONGUE PARALYSIS (tongue deviation to right), DIPLOPIA (double vision), TONGUE BITING (tongue biting) and DYSPHAGIA (difficulty swallowing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging brain: normal (normal) Normal. On an unknown date, Magnetic resonance imaging spinal: normal (normal) Normal. On an unknown date, Physical examination: negative (Negative) Negative.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had difficulty swallowing (swallow test was negative), stroke tests were negative. His Neuro-physiologist is doing a neurophysiology count (result is pending).  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the information provided, a causal association between the reported event and cranial nerves deficit is assessed as unlikely based on diagnostic test.  However, based on temporality, causality with the other reported events of dysphagia, tongue biting and deviation and double vision cannot be excluded.