Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Ear discomfort, Head discomfort, Rash
Clinical narrative: extensive rash on injection arm/extensive rash on shins below each knee; unsteadiness/off-balance; seemingly head congestion; Full ears; light headiness, constant; head pressure, constant and uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (unsteadiness/off-balance), HEAD DISCOMFORT (seemingly head congestion), EAR DISCOMFORT (Full ears), DIZZINESS (light headiness, constant) and HEAD DISCOMFORT (head pressure, constant and uncomfortable) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031321A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BALANCE DISORDER (unsteadiness/off-balance), HEAD DISCOMFORT (seemingly head congestion), EAR DISCOMFORT (Full ears), DIZZINESS (light headiness, constant) and HEAD DISCOMFORT (head pressure, constant and uncomfortable). On 22-Apr-2021, the patient experienced RASH (extensive rash on injection arm/extensive rash on shins below each knee). The patient was treated with PREDNISONE on 19-Apr-2021 at a dose of 20 mg once a day; PREDNISONE on 23-Apr-2021 at a dose of Second Course:10 mg Dose Pack; "Z" pack  6 days beginning; PREDNISONE on 30-Apr-2021 at a dose of 10 mg twice a day; AZITHROMYCIN on 23-Apr-2021 at a dose of 250 mg once a day; SULFAMETHOXAZOLE on 30-Apr-2021 at a dose of 800 mg once a day and TRIMETHOPRIM on 30-Apr-2021 at a dose of 160 mg once a day. On 25-Apr-2021, RASH (extensive rash on injection arm/extensive rash on shins below each knee) outcome was unknown. At the time of the report, BALANCE DISORDER (unsteadiness/off-balance), HEAD DISCOMFORT (seemingly head congestion), EAR DISCOMFORT (Full ears), DIZZINESS (light headiness, constant) and HEAD DISCOMFORT (head pressure, constant and uncomfortable) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Medical history for the condition includes : she treated that as a sinus problem from 4/19/2021 through 4/29/2021 trying different medications, when her two courses of medications, detailed above, had no impact she referred him to an ENT, ENT Specialist; April 29, 2021 after he visually observed the patient ears, throat, and nostrils he said he found no overwhelming physical evidence of a sinus problem. He performed the Dix-Hallpike maneuver several times testing for BPPV - he said this test showed no BPPV. In another attempt to treat a possible sinus/ear infection he prescribed the third course of medications. He was suggested three actions for him to arrange: 1) consult my Cardiologist & (Physician1) to ensure he have no heart condition; 2) have (Physician1) complete a blood panel on him to look for abnormalities; & 3) for me to monitor my blood pressure when he had a spell. Patient went to Cardiologist for EKG test on April 29,2021 and it found to be normal and it was performed by (Physician3). And it was also performed by (Physician1) on same date the results found to be normal. Physician 1 also did a blood draw on April 29, 2021 the results found to be normal. After three imbalance spells at home, patient took his blood pressure with his own cuff it was normal.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Medical history and treatment details was updated.