Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Headache, Intracranial pressure increased, Pain in extremity
Clinical narrative: intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems.  She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen,  that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the  clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she  fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.