Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically significant; Inflamed gums; Abscessed teeth on her lower jaw; some kind of side reaction; My gums and the roof of my mouth (Incomplete sentence)/my gums were so raw, I couldn't brush my teeth; My mouth became all inflamed; I have a very hard time hearing you; Equilibrium affected; But I am still deaf in my right ear; This is a spontaneous report from a contactable Nurse (patient). An 81-year-old female nurse received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0169; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 12May2021 20:00 (at the age of 81-year-old) at a 2nd dose, single for COVID-19 immunization. Medical history included 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), banana, avocado, and kiwi allergy (stated all are interrelated because they are cousins to the rubber tree plant. Also, healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is metamucil); psyllium allergy (patient 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), flu (every flu shot she received, she has gotten the flu and only takes periodically. She had to take in 2016 and 2015. It had been 5-10 years before that, and another 5-10 years before that), latex allergy (since the 1980's), shingles (having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. Stated it was a mild case. Patient gets the shingles vaccine and gets the shingles, gets the flu vaccine and gets the flu), atrial tachycardia from 2015 to an unknown date, anaphylactic reaction to a metapower bar from 2015 to an unknown date (about 7 minutes after eating the bar, she went into a severe reaction). Concomitant medications included levothyroxine tablet at a dose of 50 ug, 1x/day, vitamin B complex and akurit (not clarified hence not captured in tab). The patient previously took first dose of BNT162B2 (Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), administered in arm left on 21Apr2021 09:00 for COVID-19 immunization and experienced deaf in my right ear, I woke up with pressure in both of my ears, I could not hear and arm soreness. The patient drug history included synthroid from an unknown date to ongoing (started about 15 years ago) for low thyroid hormone, simvastatin from an unknown date to ongoing (started about a year ago) for cholesterol is slightly elevated, ocuvite preservision from an unknown date to ongoing (taking about 3 years. Macular degeneration has not changed or gotten worse in 3 years) for macular degeneration age related, vitamin D3 (taking for 3 years) for bone health from an unspecified date to ongoing, calcium with magnesium (it has calcium citrate. Been taking a long time. 5-10 years) to prevent osteoporosis, glucosamine chondroitin (taking since late 1990s. About 20 years) for joint health from an unspecified date to ongoing, vitamin C (about 3 years ago. started with the Ocuvite. Eye doctor though it was a good idea to take together), multivitamin (taking since 1995 or 1996. about 25 years) for general health; metoprolol ER for atrial tachycardia from Jan2016 to an unspecified date, baby aspirin from Jan2016 to ongoing (81 mg daily, cardiologist thought it would be a good idea). The patient reported, she received first Pfizer vaccine on 21Apr2021 and equilibrium affected and on 28Apr2021 she could not hear in her right ear and the day before on 27Apr2021 it was like she woke up with pressure in both of her ears. It sounded like heck 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 she was still deaf in her right ear. She got second vaccine on 12May2021 and on 16May2021 and 17May2021 her gums and the roof of my mouth became all inflamed and her teeth were so sore she felt like she had an abscessed tooth. My gums were so raw, couldn't brush my teeth. So she gargle with some peroxide and some saline and then her teeth were sore like you have an abscess teeth on lower jaw. And then that went away within two days. Pressure in both ears has subsided, but then confirms it is a lasting effect comes and goes a little bit from 27Apr2021 to ongoing. First the doctor put her on valacyclovir and methylprednisone 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Started 05May2021 for 7 days. And then last week he started me on the dexamethasone injections through tympanic membrane into her middle ear last Thursday, 20May2021. 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. States cortisone decreases irritation and inflammation. Adds she is 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events I am still deaf in my right ear, I have a very hard time hearing you was not recovered; equilibrium affected, some kind of side reaction was unknown; my teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw, inflamed gums, abscessed teeth on her lower jaw, my gums and the roof of my mouth (incomplete sentence)/my gums were so raw, I couldn't brush my teeth, my mouth became all inflamed was recovered on an unspecified date in 2021.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, unilateral deafness, non infective gingivitis, tooth abcess, toothache, balance disorder cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate