Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Ear congestion, Ear, nose and throat examination, Facial paralysis
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (left eye is not blinking completely) and DEAFNESS UNILATERAL (loss of hearing in the left ear) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced DEAFNESS UNILATERAL (loss of hearing in the left ear) (seriousness criterion medically significant) and EAR CONGESTION (congestion feeling in the left ear, feels like its plugged up). On 29-Apr-2021, the patient experienced FACIAL PARALYSIS (left eye is not blinking completely) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (left side mouth numb, does not have as much control on left side of mouth) and LACRIMATION INCREASED (left eye tearing excessively). At the time of the report, FACIAL PARALYSIS (left eye is not blinking completely), DEAFNESS UNILATERAL (loss of hearing in the left ear), HYPOAESTHESIA ORAL (left side mouth numb, does not have as much control on left side of mouth), EAR CONGESTION (congestion feeling in the left ear, feels like its plugged up) and LACRIMATION INCREASED (left eye tearing excessively) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Physical examination: abnormal (abnormal) Patient was told by a physician there was fluid in the ear.. On 29-Apr-2021, Acoustic stimulation tests: abnormal (abnormal) Based on the results of a hearing test, the ENT told her that he believes her symptoms are due to a nerve issue that is affecting the muscles on the left side of the face.. On 29-Apr-2021, Ear, nose and throat examination: normal (normal) The ENT specialist's examination found no infection and no fluid in ear..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There are no routine concomitant prescription or over-the-counter medications.  Treatment included antibiotic doxycycline hyclate 100 mg twice a day for ear symptoms, prescribed by a physician who was seen on 23-Apr-2021. A 13-day prednisone taper was prescribed by an ENT (Ear, Nose, and Throat physician/ otolaryngologist) who was seen on 29-Apr-2021.The patient is currently still taking the antibiotic.  Thursday 29Apr2021, she visited an ear, nose, and throat (ENT) specialist for her ear symptoms.  The ENT specialist's examination found no infection and found no fluid in her left ear.  The ENT told her that the antibiotic therapy would not have caused this type of reaction and told her the symptoms may be due to the Moderna Covid-19 vaccine dose. Based on the results of a hearing test which she was given which was ordered by the ENT because of the symptoms, the ENT told her that he believes that her symptoms are due to a nerve issue that is affecting the muscles on the left side of the face.  The ENT told her that he has had other patients with similar symptoms after receiving a second dose of Covid-19 vaccine, which are referenced in the cross-linked case. The ENT prescribed a steroid, Prednisone 10 mg, for the symptoms.  She started the Prednisone steroid taper on 29Apr2021, describing the Prednisone 10 mg taper to be decreasing by one tablet a day for 13 days.  She is still currently taking the Prednisone taper.  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.