Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Deafness, Ear discomfort, Hypoacusis
Clinical narrative: Equilibrium affected; I could not hear; I woke up with pressure in both of my ears; Deaf in my right ear; arm soreness; This is a spontaneous report received from a contactable Nurse (patient). An 81-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 21Apr2021 at 09:00 as 1st DOSE, SINGLE for covid-19 immunization. Medical history included atrial tachycardia (From: 2015 To: Unspecified), macular degeneration diagnosed about 3-5 years ago, low thyroid hormone seems like she's had forever, high cholesterol just beyond normal has had for years, latex allergy since the 1980's, banana, avocado, and kiwi allergy (states all are interrelated because they are cousins to the rubber tree plant and also healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is Metamucil), Psyllium allergy (states she had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight. thankfully was at work). Reported having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. States it was a mild case. NDC, lot, expiry unknown. She stated every flu shot she received, she has gotten the flu and only takes periodically. States she retired in 2017 and had to take in 2016 and 2015, she would have lost her job if she didn't take. It had been 5-10 years before that, and another 5-10 years before that. States she stays away from the flu shot. Concomitant medications included metoprolol ER from Jan 2016 for atrial tachycardia, SYNTHROID started about 15 years ago for low thyroid hormone, Simvastatin ongoing, started about a year ago for cholesterol slightly elevated, OCUVITE PreserVision(Ongoing) taking about 3 years for macular degeneration age related has not changed or gotten worse in 3 years, baby aspirin started Jan 2016 (Ongoing) as cardiologist thought it would be a good idea, Vitamin D3: taking for 3 years (ongoing) for bone health, calcium with magnesium been taking a long time. 5-10 years to prevent osteoporosis (ongoing), glucosamine chondroitin taking since late 1990s. about 20 years for joint health (ongoing), multivitamin taking since 1995 or 1996. about 25 years for general health, vitamin C about 3 years ago started with the Ocuvite (eye doctor though it was a good idea to take together.   On April 28th2021 patient could not hear. She was deaf in right ear and the day before on April 27 it was like she woke up with pressure in both ears. It sounded like hell like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and still deaf in right ear." She confirmed pressure is gone, but still deaf and under medical treatment with otolaryngology. She was kind of tossing whether to get the vaccine or not. First went to family doctor to see, didn't think she had an ear infection because no pain and was hoping maybe she would have wax in her ear, but ears were clean and no wax. So they sent her to an ear specialist and they did hearing test and she has pretty severe hearing loss in that ear. So she was still being treated. First the doctor put her on valacyclovir and methylprednisone for about 7 days and then that didn't seem to do anything and now she's getting dexamethasone injections into her middle ear. States she is due for one about lunch time. Pressure in both ears: patient reported has subsided, but then confirms it is a lasting effect comes and goes a little bit. Left ear is pretty much clear but right ear still has pressure and cannot hear and has not subsided. On an unknown date her equilibrium affected and stated has gotten slightly better, minuscule. Patient added she's pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. Patient was treated with Valacyclovir: 1 gram tablet every 6 or 8 hours, states can't remember. Started 05MAY2021 for 7 days. Caller confirmed it did not help and she threw bottle away. Methylprednisone: 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Confirmed she threw package away. Stated cortisone decreases irritation and inflammation. And Valacyclovir is an antiviral. Started dexamethasone injections last Thursday, 20 May 2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help she will have an MRI. Airborne: started taking about one week ago after first dexamethasone injection through tympanic membrane into middle ear. Relevant Tests: Hearing Test (Date: 05MAY2021)Result: pretty severe hearing loss in right ear, Test: Ear exam (Date: 03MAY2021; 05MAY2021) Result: Normal. Outcome for pain in extremity was recovered, for ear discomfort and deafness it was resolving, for hypoacusis and. equilibrium affected it was unknown.  Reporter seriousness for pressure in both ears and equilibrium affected: Medically significant, Deafness right ear: Disabling, Arm soreness: non-serious  Reporter causality: deafness in right ear: Causality: strong suspicion it's related to the vaccine, maybe not necessarily the vaccine itself, but her immune system reaction to the vaccine. Causality for pressure in both ear, arm soreness and equilibrium: related; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  events such as deafness,balance disorder and ear discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.