Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent; numbness on toes of his right foot; difficulty moving his right leg to use break pedal while driving his car; right foot was not going on the ground during his walk; left ear started buzzing with hollow sound which gradually increased every week; feeling tickling; Pain in hand; Numbness on fingers; started feeling that skin bellow his eye and right side of his face was falling; fever; pain in his right arm; shivering; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent), HYPOAESTHESIA (numbness on toes of his right foot), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car) and GAIT DISTURBANCE (right foot was not going on the ground during his walk) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), SEMAGLUTIDE (RYBELSUS) and ATORVASTATIN for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSAESTHESIA (started feeling that skin bellow his eye and right side of his face was falling). On an unknown date, the patient experienced DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent) (seriousness criterion medically significant), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car) (seriousness criterion medically significant), PARAESTHESIA (feeling tickling), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness on fingers). an unknown date, the patient experienced HYPOAESTHESIA (numbness on toes of his right foot) (seriousness criterion medically significant) and GAIT DISTURBANCE (right foot was not going on the ground during his walk) (seriousness criterion medically significant). an unknown date, the patient experienced TINNITUS (left ear started buzzing with hollow sound which gradually increased every week). an unknown date, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain in his right arm) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent), HYPOAESTHESIA (numbness on toes of his right foot), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car), GAIT DISTURBANCE (right foot was not going on the ground during his walk), DYSAESTHESIA (started feeling that skin bellow his eye and right side of his face was falling), TINNITUS (left ear started buzzing with hollow sound which gradually increased every week), PARAESTHESIA (feeling tickling), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness on fingers) outcome was unknown and PYREXIA (fever), VACCINATION SITE PAIN (pain in his right arm) and CHILLS (shivering) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Acoustic stimulation tests: abnormal (abnormal) 40 to 50 % of hearing loss on left side and mentioned that his right ear is also affected as well but not to the great extent..         After 24 hours of the second dose patient developed shivering, fever and pain in his right arm which lasted for 2 to 3 days. Patient could not get out of bed and had to take Tylenol to treat the symptoms. After 5 days, patient started feeling normal. Patient stated that 1 week after the second dose, his left ear started buzzing with hollow sound which gradually increased every week. Patient was referred to ENT specialist by his primary care doctor. ENT doctor performed hearing test and diagnosed the patient with 40 to 50 % of hearing loss on left side and mentioned that his right ear is also affected as well but not to the great extent. Patient stated that After 10 days (on 26/27May2021), his right foot was not going on the ground during his walk and started feeling tickling, numbness on toes of his right foot. Patient mentioned that the numbness kept going upwards and towards under his knee. One or two weeks ago, patient was having difficulty moving his right leg to use break pedal while driving his car. Patient stated that he is walking, running on treadmill and doing yoga daily. Patient's walking got a little better but he still has numbness in his toes. Patient was told to get ABR test done and might need MRI test. Two weeks back from today (16Jul2021), Patient started feeling that skin bellow his eye and right side of his face was falling. Patient confirmed that he is still feeling the same. Patient informed his doctor about the symptoms and he was referred to a neurologist. Patient has an appointment with neurologist on 04AUG2021. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company Comment: 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.; 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.