Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sudden hearing loss; feeling cold; Nausea; Fatigue; Muscle aches; Fever of 101; Began violently shaking and it was so bad was scared; Ringing in right ear; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 20-Dec-2020 and Transient ischaemic attack (Right patient foramen ovale). Concurrent medical conditions included Penicillin allergy, Drug allergy (Lisinopril), Blood pressure high since 2010 and Arthritis. Concomitant products included METOPROLOL for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Transient ischaemic attack, VITAMIN D3 for Vitamin deficiency, FISH OIL and PNEUMOCOCCAL VACCINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). On 11-Feb-2021, the patient experienced TREMOR (Began violently shaking and it was so bad was scared), TINNITUS (Ringing in right ear), PYREXIA (Fever of 101), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On an unknown date, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant), FEELING COLD (feeling cold) and NAUSEA (Nausea). On 14-Feb-2021, TREMOR (Began violently shaking and it was so bad was scared), PYREXIA (Fever of 101), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and TINNITUS (Ringing in right ear) had not resolved and FEELING COLD (feeling cold), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 11-Feb-2021, Body temperature: 101.8 (High) Temperature of 101.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication, fish oil was used for heart health.  On 11 Feb 2021, patient woke up with severe shaking which felt different from fever and chills. Patient shook so hard and was not able to open the bottle of ibuprofen and had to ask for help. Patient was totally alert during the severe shaking and was continued to shake for about four hours. Along with it patient experienced temperature of 101.8 about two hours, fatigue, muscle aches nausea and ringing in right ear. The ringing in right ear continued since.  Three weeks after the vaccination, patient went to an ENT and was diagnosed with sudden hearing loss probably related to a virus. Patient was given tapered dose of steroids to take for 2 weeks and returned to the office for follow up. Nothing had changed. Patient made another appointment with another ENT who wants patient to have a magnetic resonance imaging done next week..  Treatment information included ibuprofen 600 mg, tylenol 650mg and steroids.  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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up was received included reporter information, patient demographics, historical conditions, laboratory data, concomitant medications, vaccine information, additional events (sudden hearing loss, ringing in right ear, fatigue, muscle aches, nausea) and upgraded to serious case due to the medically significant event sudden hearing loss.; 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.