Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear pain, Headache, Hypoacusis, Hypoaesthesia
Clinical narrative: Hearing in her right ear is now muffled; Places her finger in her right ear, it feels numb; Couldn't get off the couch; Vomiting; Dizziness; Vertigo/Felt spinning all day long; No hearing in right ear; Left earache; Beeping noise right ear; Nauseated; Neck and shoulders were also achy; Head felt like it would explode; Ears were full of pressure; Neck and shoulders were also achy; Chills; Body aches; A spontaneous report, was received from a consumer (patient), a 46 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced no hearing in right ear (deafness unilateral), ears were full of pressure (ear congestion), neck and shoulders were also achy (neck pain), left earache (ear pan), beeping noise right ear (tinnitus), hearing in her right ear is now muffled (hypoacusis), place her finger in her right ear, it feels numb (hypoaesthesia), body aches (pain), dizziness, couldn't get off the couch (asthenia), vertigo/felt spinning all day long (vertigo), chills, neck and shoulders were also achy (arthralgia), head felt like it would explode (headaches), nauseated (nausea), and vomiting.  The patient's medical history included ear infection as a child, hysterectomy (5 years ago) and knee surgery (8 years ago). The patient was allergic to penicillin and sulfa drugs. Concomitant medications were not reported.   On 09 Feb 2021, prior to the onset one events, the patient received the second of planned doses of mRNA-1273 (Lot number: 001A21A), intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, after administering the vaccine, at night she started experiencing a bad reaction which includes body aches and chills. On 10 Feb 2021, in the morning, the patient head felt like it would explode, reported headaches, and her ears were full of pressure. She stated that her neck and shoulders were also achy. The patient stated that she took acetaminophen as treatment medication. On 11 Feb 2021, in the morning, the patient had a left earache and no hearing in right ear except a beeping noise. The patient also stated that she was feeling nauseated and called her primary healthcare professional and was advised to go to urgent care on the same day. The patient stated that she was prescribed prednisone (one tablet three times a week) and ear infection was ruled out. On 13 Feb 2021, the patient experienced vertigo, dizziness, but body aches were mostly gone. On 14 Feb 2021, the patient stated that it was the worst day, as she couldn't get off the couch, felt spinning all day long, and was vomiting. On 15 Feb 2021, the patient reported that she threw up in the morning and was nauseated and dizzy. The patient stated that she then went to see ear nose throat (ENT) specialist. It was reported that the findings from ENT Specialist was hearing loss in right ear and was prescribed a prednisone dose pack and unknown anti-nausea medication. On 23 Feb 2021, the patient stated that the hearing in her right ear was now muffled and can't hear high pitch in right ear. The patient stated that the hearing loss was ongoing and was still experiencing headaches. The patient stated that she currently isn't working and can't drive. The patient also stated that if she places her finger in right ear, it feels numb. The patient stated that she was scheduled to have a magnetic resonance imaging (MRI) done on 10 Mar 2021, if her hearing doesn't return.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.   The outcome of the events, no hearing in right ear, ears were full of pressure, left earache, hearing in her right ear is now muffled, place her finger in her right ear, it feels numb, head felt like it would explode, were considered as not recovered; that of event body aches was considered as recovering/resolving; that of events neck and shoulders were also achy, beeping noise right ear, dizziness, couldn't get off the couch, vertigo/felt spinning all day long, chills, neck and shoulders were also achy, nauseated and vomiting, were considered as unknown.; Reporter'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.