Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure decreased, Diplopia, Dizziness, Ear infection
Clinical narrative: Wobbly; Sees double; BP dropped; Fluid behind ears; Lower back pain; Ear infection; Severe Vertigo; Dizziness; A spontaneous report was received from a consumer who was also a 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo (vertigo), dizziness, ear infection, fluid behind her ears (middle ear efflusion), being wobbly (gait disturbance), seeing double (diplopia), lower back pain (back pain), and blood pressure dropped (blood pressure decreased).   The patient's medical history included arthritis and migraine. Products known to have been used by the patient included fluticasone propionate/ salmeterol xinafoate, botulinum type A, duloxetine hydrochloride, hydrochlorothiazide (HCTZ), umeclidinium bromide, atorvastatin calcium, gabapentin, raloxifene, sumatriptan, telmisartan, cetirizine hydrochloride, cholecalciferol, calcium, zinc, probiotics, apoaequorin, and galcanezumab-gnlm.  On 14 Jan 2021, the patient saw an ear doctor for ear pain. Treatment included steroids and eardrops that were antibiotics.  On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 26 Jan 2021, approximately 3 days after the mRNA-1273 vaccine was given, the patient noted she started getting severe vertigo or dizziness.   On 28 Jan 2021, she saw her physician who attributed the dizziness to an ear infection that went undiagnosed. She also had fluid behind her ears.  On 28 Jan 2021, a different doctor informed her that her eardrops were not going to touch the ear infection she had and prescribed amoxicillin. She reported that she still has dizziness. She stated that she was still wobbly and sees double. She then saw an ophthalmologist for her double vision and his concern was that it was not an eye issue more of a head issue and should be checked for a transient ischemic attack (TIA) or stroke. She then went to the emergency room (ER) to get it checked out and left the ER after waiting over 2 hours. The triage nurse at the ER told her that she was beyond any help since it was after 90 minute window if she had a stroke. She was attempting to get a CT scan of her head done. She was given pain medication as well for lower back pain. She was taken off the HCTZ because blood pressure dropped after getting the vaccine.   Consent to contact was obtained.  Treatment information included amoxicillin, meclizine and pain medication.  Action taken with mRNA-1273 was not reported.  The outcome of the events, severe vertigo, and/or dizziness, ear infection, fluid behind her ears, being wobbly and seeing double, lower back pain and blood pressure dropped, was not resolved.; Reporter's Comments: Based on the information provided the event of ear infection is unlikely related to the vaccine administration as event was pre-existing  , Although a temporal association exist between the other events and mRNA-1273, critical details is lacking as patient is of an advanced age and has an undisclosed cardiac condition (on treatment with HCTZ ). .  Hence, there is not enough information to adequately assess association with mRNA-1273 at this time.