Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis, Dizziness
Clinical narrative: vertical heterophoria; fatigue; memory deficits; dizziness/vertigo; dizziness/vertigo; tinnitus hyperacusis; tinnitus hyperacusis; headache; This is a spontaneous report received from contactable reporter(s) (Physician).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "adjustment disorder" (ongoing), notes: persistent symptoms; "Nicotine dependence" (ongoing); "Fibromyalgia" (ongoing), notes: intermittent ; "Herpes Simplex type I" (ongoing), notes: intermittent ; "vertigo" (ongoing); "Migraine Headache" (ongoing); "tobacco abuse"; "GI symptoms"; "Depression"; "pain"; "obesity". Concomitant medication(s) included: CELEXA [CELECOXIB] taken for depression (ongoing); DICYCLOMINE oral taken for gastrointestinal disorder, start date: 26May2021, stop date: 2021; GABAPENTIN oral taken for pain; NAPROXEN oral taken for pain. Vaccination history included: BNT162b2 (DOSE 1, Anatomical site of injection: Deltoid, Route of administration: Intramuscular), administration date: 19Dec2020, when the patient was 44-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (disability), VERTIGO (disability) all with onset Mar2021, outcome "not recovered" and all described as "dizziness/vertigo"; TINNITUS (disability), HYPERACUSIS (disability) all with onset Mar2021, outcome "not recovered" and all described as "tinnitus hyperacusis"; FATIGUE (disability) with onset Apr2021, outcome "not recovered"; MEMORY IMPAIRMENT (disability) with onset Apr2021, outcome "not recovered", described as "memory deficits"; HEADACHE (medically significant) with onset 2021, outcome "unknown"; HETEROPHORIA (medically significant) with onset 20Dec2022, outcome "recovering", described as "vertical heterophoria". The events "dizziness/vertigo", "fatigue", "memory deficits", "vertical heterophoria" and "headache" required physician office visit. The event "tinnitus hyperacusis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (26Jul2021) No bleeding diverticula colon otherwise normal; Computerised tomogram abdomen: (28Apr2021) No acute finding, notes: diverticulosis without diverticulitis; Computerised tomogram head: (08Jan2022) No acute intra-cranial abnormality; Computerised tomogram pelvis: (28Apr2021) No acute finding, notes: diverticulosis without diverticulitis; Magnetic resonance imaging head: (08Jan2022) Normal MRI brain; SARS-CoV-2 test: (20Dec2021) 191.0, notes: Ab detected against Sars Cov-2. Therapeutic measures were taken as a result of dizziness, vertigo, tinnitus, hyperacusis, headache. Therapeutic measures were not taken as a result of fatigue, memory impairment, heterophoria. Clinical course: The patient experienced persistent symptoms of fatigue, headache, tinnitus, vertigo and memory deficits. This consultation of symptoms affected has ability to continue working on a computer and information technologist. She has received care at ENT, Neurology, ophthalmology, and primary care. Numerous interventions to include treating migraine ophotho (word not legible) assessment and vestibular testing have helped however, she reports persistent challenge with tinnitus and migraine. The reporting physician did not consider the Pfizer product had a causal effect to the adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The information available in this report is very limited and does not allow a medically meaningful assessment of the case. Based on the temporal relationship between the administration of the BNT162b2 vaccine and the onset dates of the reported events, the patient medical history, the confounding factor represented by multiple concomitant medications, and the physician assessment, it is unlikely that the reported events are related to the suspect drug. Case will be reassessed should follow-up information become available. 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.,Linked Report(s) : US-PFIZER INC-202201042502 same patient, different vaccine dose/event;