Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Biopsy, Blood pressure measurement, Colonoscopy, Computerised tomogram
Clinical narrative: Seizure disorder/behavioral seizure/severe mental status changes/agitation/seizure activity; Left arm neuropathy; MRI of brain with tissue malacia but no active tumor/ CT scan brain and cervical spine-with no active disease but malacia; Peeling of on her hands and feet, and that are painful/her hands and feet still peel some but not near as tender to touch; Dry mucosa cause of bleeding; UTI; She wants to eat but when she eats there is no taste; Decreased appetite/very poor appetite; Hypothyroidism; Forgetfulness; Pain score 10/10; CT scan brain and cervical spine-with no active disease but malacia; Inappropriate mood and affect; Chronically ill- appearing; Panic attacks/ just feeling like she is a burden on everybody; Losing weight; This is a solicited report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): CABO-22051890 (Agency).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 as dose 2, single (Batch/Lot number: unknown), all unknown for immunisation; cabozantinib S-malate (CABOMETYX), first regimen from 01Oct2020 (Batch/Lot number: unknown) to 27Nov2020 at 60 mg daily (60 mg, qd), second regimen since Dec2020 (Batch/Lot number: unknown) at 60 mg alternate day (60 mg, qod), third regimen (Batch/Lot number: unknown) till 05Jan2021 at 60 mg daily (60 mg, qd), fourth regimen since Jan2021 (Batch/Lot number: unknown) at 60 mg daily (60 mg, qd), fifth regimen (Batch/Lot number: unknown) at 60 mg daily (60 mg, qd) and sixth regimen (ongoing) (Batch/Lot number: unknown) at 60 mg daily (60 mg, qd), all oral for lung neoplasm malignant, metastases to central nervous system. The patient's relevant medical history included: "Pain" (unspecified if ongoing); "Radiotherapy to brain NOS" (unspecified if ongoing); "Anxiety state", start date: 13Sep2012 (unknown if ongoing); "Essential hypertension, benign", start date: 13Sep2012 (unknown if ongoing); "Tobacco user", start date: 13Sep2012 (ongoing); "Auditory disorder NOS", start date: 12May2016 (unknown if ongoing); "Dermatophytosis", start date: 12May2016 (unknown if ongoing); "Onychomycosis", start date: 12May2016 (unknown if ongoing); "Low back pain", start date: 12Sep2014 (unknown if ongoing); "Pain in joint involving hand", start date: 30Jan2018 (unknown if ongoing); "Carpal tunnel syndrome", start date: 30Jan2018 (unknown if ongoing); "Abdominal pain", start date: 09Mar2020 (unknown if ongoing); "Cough" (unspecified if ongoing); "Brain tumor operation" (unspecified if ongoing); "Stroke" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; ATENOLOL; HYOSCYAMINE SULFATE; KEPPRA [LEVETIRACETAM]; LISINOPRIL; CHOLECALCIFEROL; HYDROCHLOROTHIAZID. Past drug history included: Dxm (dextromethorphan); Td (adult), start date: 22Jun2005, stop date: 22Jun2005, for Immunization; Adsorbed (td (adult), start date: 22Jun2005, stop date: 22Jun2005, for Immunization. The following information was reported: WEIGHT DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "Losing weight"; ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "Chronically ill- appearing"; INAPPROPRIATE AFFECT (non-serious) with onset 09Dec2021, outcome "unknown", described as "Inappropriate mood and affect"; PANIC ATTACK (non-serious) with onset Dec2021, outcome "unknown", described as "Panic attacks/ just feeling like she is a burden on everybody"; MYELOMALACIA (medically significant) with onset Feb2022, outcome "unknown", described as "CT scan brain and cervical spine-with no active disease but malacia"; PAIN (non-serious) with onset 13Apr2022, outcome "unknown", described as "Pain score 10/10"; SEIZURE (hospitalization, medically significant), outcome "unknown", described as "Seizure disorder/behavioral seizure/severe mental status changes/agitation/seizure activity"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Left arm neuropathy"; ENCEPHALOMALACIA (medically significant), outcome "unknown", described as "MRI of brain with tissue malacia but no active tumor/ CT scan brain and cervical spine-with no active disease but malacia"; AGEUSIA (non-serious), outcome "unknown", described as "She wants to eat but when she eats there is no taste"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "Peeling of on her hands and feet, and that are painful/her hands and feet still peel some but not near as tender to touch"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Dry mucosa cause of bleeding"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; DECREASED APPETITE (non-serious), outcome "recovering", described as "Decreased appetite/very poor appetite"; HYPOTHYROIDISM (non-serious), outcome "unknown"; MEMORY IMPAIRMENT (non-serious), outcome "recovered", described as "Forgetfulness". The patient was hospitalized for seizure (start date: Aug2021). The patient underwent the following laboratory tests and procedures: Biopsy: (16Sep2020) KRAS positive; Blood pressure measurement: (08Oct2020) slightly elevated; Colonoscopy: (unspecified date) diagnosis of colitis; Computerised tomogram: (2020) result not provided; (26Jan2021) showed retroversion of uterus and ovarian cyst, notes: NOS bilateral; (26Jan2021) showed thyroid nodule-bilateral/ several poorly, notes: defined nodules; (16Sep2020) liver lesions; (Feb2022) with no active disease but malacia; Culture urine: (03May2017) POSITIVE; Electroencephalogram: (19Apr2021) abnormal EEG monitoring suggestive of seizure, notes: disorder; Imaging procedure: (unspecified date) stable; slight decrease in dz (disease); PDL-1: (16Sep2020) positive at 2%; (16Sep2020) 0; (27Oct2020) 0; (01Dec2020) 0; (09Dec2021) 0; Magnetic resonance imaging head: (unspecified date) showed tissue malacia but no active tumor; (16Sep2020) 3 lesions; 1 post stroke/TIA, other 2 lesions, notes: metastatic brain cancer; likely primary lung; (19Apr2021) residual 6 mm metastatic lesion. non active; (13Jan2022) Stable; Pain assessment (normal high range 10): (16Sep2020) 0/10; (01Oct2020) 0/10, notes: method: Numeric Pain Intensity Scale; (13Apr2022) 10/10; Skin test: (01Dec2020) showed bilateral fingertip ungual, erythematous, notes: tenderness on palpation; Weight: (Apr2021) losing weight. The action taken for cabozantinib S-malate was temporarily withdrawn. Therapeutic measures were taken as a result of seizure, neuropathy peripheral, skin exfoliation, nasal dryness, urinary tract infection, weight decreased, hypothyroidism.  The reporter's assessment of the causal relationship of "seizure disorder/behavioral seizure/severe mental status changes/agitation/seizure activity", "left arm neuropathy", "mri of brain with tissue malacia but no active tumor/ ct scan brain and cervical spine-with no active disease but malacia", "ct scan brain and cervical spine-with no active disease but malacia", "she wants to eat but when she eats there is no taste", "panic attacks/ just feeling like she is a burden on everybody", "peeling of on her hands and feet, and that are painful/her hands and feet still peel some but not near as tender to touch", "dry mucosa cause of bleeding", "uti", "inappropriate mood and affect", "chronically ill- appearing", "pain score 10/10", "decreased appetite/very poor appetite", "losing weight", "hypothyroidism" and "forgetfulness" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course: On an unknown date in Apr 2021, the patient had very poor appetite and was losing weight (weight decreased) and had some diarrhea but controllable with Imodium. On 20 May 2021, the patient was started on dronabinol route 5mg/m2 1 to 3 hours prior to chemotherapy, then every 2 to 4 hrs after chemoas needed, for a total of 4-6 doses daily. On an unknown date, the patient was diagnosed with hypothyroidism. On 09 Jul 2021, the patient was started on levothyroxine 1 tablet (50 ug) qd oral for hypothyroidism. On an unknown date in Aug 2021, the patient was hospitalized with severe mental status changes and agitation, thought as been behavioral seizures, a third seizure medication was added and had been monitored by neurology. On an unknown date, MRI of the brain showed tissue malacia (encephalomalacia) but no active tumor, additionally UTI (urinary tract infection) was treated and hematochezia resulting in colonoscopy and diagnosis of colitis. On an unknown date in Dec 2021, the patient was just feeling like she was a burden on everybody, was taken to ER the other night and they said she was having panic attacks (panic attack). On 09 Dec 2021, the patient was chronically ill-appearing (illness), had inappropriate mood and affect (inappropriate affect) and PHQ-2 score was 0. Seizure was controlled on current therapy. As on 03 Feb 2022, there were no seizures and patient was still on Keppra with normal blood level. On 13 Jan 2022, MRI was stable. On an unknown date, the patient was seen in ER due to seizure activity. On an unknown date, the patient had increasing diarrhea, had seen some bright blood in the stool and experienced left arm neuropathy (neuropathy peripheral). On an unknown date in Feb 2022, CT scan of the brain and cervical spine was performed with no active disease but malacia (myelomalacia). On 28 Feb 2022, the patient was started on Gabapentin 1 capsule (100 mg) tid oral for neuropathy peripheral. On 13 Apr 2022, pain score was 10/10 (pain). On an unknown date, the patient experienced forgetfulness (memory impairment) due to which the patient missed one dose (product dose omission issue) of Cabometyx. Further the physician reported that the event memory impairment was not due to Cabometyx. The patient was on seizure control medication (unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.