Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Balance disorder, Blood test, Cervical spinal stenosis, Computerised tomogram
Clinical narrative: could barely walk/Almost couldn't walk; cervical stenosis; felt so unstable/felt completely unstable/doesn't feel stable; feelings of dizziness; migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; vestibular migraine; central vestibular issues; fell on carpet; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "mild Covid", start date: Jun2024 (unspecified if ongoing), notes: Had mild Covid in Jun2024, took Paxlovid for it; "migraines", start date: 2017 (unspecified if ongoing); "Aura symptoms", start date: 2017 (unspecified if ongoing); "tinnitus and ringing", start date: 2017 (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip" (unspecified if ongoing); "two legs are different lengths" (unspecified if ongoing); "two legs are different lengths affecting balance" (unspecified if ongoing); "screws put in femur" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder (ongoing); VITAMIN D3. The patient also took other concomitant therapy which included a vaginal cream. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 08Sep2022, for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; BNT162b2 (DOSE 5 (BOOSTER), SINGLE), administration date: 21Apr2023, for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; BNT162b2 (DOSE 6 (BOOSTER), SINGLE), administration date: 15Sep2023, for COVID-19 immunization, reaction(s): "Tinnitus aggravated", "Migraine aggravated"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated". The following information was reported: BALANCE DISORDER (hospitalization) with onset 13Oct2024, outcome "recovering", described as "felt so unstable/felt completely unstable/doesn't feel stable"; FALL (non-serious) with onset Oct2024, outcome "unknown", described as "fell on carpet"; GAIT DISTURBANCE (hospitalization), outcome "recovering", described as "could barely walk/Almost couldn't walk"; CERVICAL SPINAL STENOSIS (hospitalization, medically significant), outcome "recovering", described as "cervical stenosis"; TINNITUS (non-serious), MIGRAINE (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent"; VESTIBULAR MIGRAINE (non-serious), outcome "unknown"; VESTIBULAR DISORDER (non-serious), outcome "unknown", described as "central vestibular issues"; DIZZINESS (non-serious), outcome "unknown", described as "feelings of dizziness". The patient was hospitalized for balance disorder, gait disturbance, cervical spinal stenosis (start date: 13Oct2024, discharge date: 14Oct2024, hospitalization duration: 2 day(s)). The events "migraines and tinnitus seem to be more frequent", "vestibular migraine", "central vestibular issues", "fell on carpet" and "feelings of dizziness" required physician office visit. The events "felt so unstable/felt completely unstable/doesn't feel stable", "could barely walk/almost couldn't walk" and "cervical stenosis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Audiogram: (unspecified date) negative, notes: Took CAT scan of ears, did audiology tests, thought problem of conduction of sound between the bone, but didn't find anything, tests were negative; Blood test: (Sep2024) Unknown results, notes: repeated multiple times; Computerised tomogram: (unspecified date) Unknown results; (unspecified date) didn't find anything, notes: Took CAT scan of ears, did audiology tests, thought problem of conduction of sound between the bone, but didn't find anything, tests were negative; full battery of tests: (Sep2024) keeps thinking vestibular migraine; Magnetic resonance imaging: (unspecified date) Unknown results; Magnetic resonance imaging head: (unspecified date) Unknown results; Spinal X-ray: (unspecified date) Unknown result; (unspecified date) no changes from prior, notes: did images in addition took x-rays of cervical spine and hips. X-rays indicated no changes from prior; X-ray of pelvis and hip: (unspecified date) Unknown result; (unspecified date) no changes from prior, notes: did images in addition took x-rays of cervical spine and hips. X-rays indicated no changes from prior. Therapeutic measures were taken as a result of balance disorder, gait disturbance, cervical spinal stenosis, tinnitus, migraine, vestibular migraine.  Clinical course: The patient already reported to CDC, not sure if a definitive cause and effect, but based on studies the patient has read from research institutions or universities. On 13Oct2024, approximately four weeks after the patient got the updated COMIRNATY vaccine/recent COMIRNATY vaccine (7th dose of Pfizer COVID vaccines, clarified she had prior doses of Pfizer COVID), the patient felt so unstable, she thought she was having a stroke, could barely walk, almost couldn't walk. It wasn't that head was spinning, she felt completely unstable. She did not have signs of stroke, other than unstable, she was concerned. The patient spent 24 hours in hospital for observation and was admitted into the hospital. She did MRI imaging of brain, CAT scan of brain. She has cervical stenosis and migraines. She is getting better, three weeks after. She has outpatient physical therapy two times a week, for balance and stability. During hospitalization, the patient had bloodwork, full blood panels, repeated multiple times. She underwent MRI of brain, CAT scan of brain, MRI of cervical spine, thoracic spine, and lumbar spine. She met with and observed by occupational therapist and physical therapist. Physical therapist thought there were central vestibular issues, also subsequent to hospital visit, saw two orthopedic specialists. Thought something was wrong because of accident caller had dating from 2010, caused partially compressed or collapsed hip, because of that feels two legs are different lengths affecting balance. 3 or 4 weeks ago around time this all happened, the patient fell on carpet on side of leg where they had screws put in her femur, they were concerned if this did something. She went to the spine orthopedist. When she went to the orthopedic group, they did images in addition and took x-rays of cervical spine and hips. X-rays indicated no changes from prior. Said what happened was not, they didn't think, attributed to stenosis. The patient also went to ENT group, seen for feelings of dizziness, and was tested. Did full battery of tests, keeps thinking vestibular migraine. Still need image of inner and middle ear to see if ear balance situation, sometimes vaccines, as well as COVID vaccine, can create inflammation there. Took CAT scan of ears, did audiology tests, thought problem of conduction of sound between the bone, but didn't find anything, tests were negative. The patient has various doctors and can contact HCP about what happened to her in the emergency room and the symptoms. The patient went to the hospital. She is also seeing a neurologist as well and has numerous specialists. Since 2017, she gets bad migraines, various aura symptoms, tinnitus and ringing. Since she started taking all of the COVID vaccines, migraines and tinnitus seem to be more frequent. That could produce this, has migraines, headaches are not severe, aura symptoms, some doctors say, like ENT and neurologist, sometimes gets migraine, has light shows with migraines. Headaches are really least significant, if she has strong moderate headache, she takes two aspirins. When getting a headache, her tinnitus starts, which is a part of migraine symptoms. When she was in the hospital for observation, PA said she was having vestibular migraine. The patient doesn't know if she had a flare up of stenosis or some really bad reaction to the COVID vaccine. She is not saying that Pfizer created this, but seems to be consistent with what the patient read in terms of reactions. This was a pretty significant thing that happened to her, hopefully stability returns to what it was. This was a very unnerving experience, she doesn't feel stable. She has to have caregiver expenses, to take showers. This was a significant medical event for the patient.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400295407 Same patient, different dose/event;US-PFIZER INC-2021058557 Same patient, different dose/event;US-PFIZER INC-202400295404 Same patient, different dose/event;US-PFIZER INC-202400295405 Same patient, different dose/event;US-PFIZER INC-202400295403 Same patient, different dose/event;US-PFIZER INC-202400295408 Same patient, different dose/event;US-PFIZER INC-202400295406 Same patient, different dose/event;