Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrospinal fluid leakage, Computerised tomogram, Computerised tomogram head, Deep vein thrombosis, Headache
Clinical narrative: DVT; CSFL; Idiopathic intracranial hypertension; get a severe pain above my right ear in my skull; Initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 21Dec2021 this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 64 -old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: EP7534) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: May2000 (ongoing), notes: Pertinent details: Medication; "Hypertension", start date: Aug1994 (ongoing), notes: Pertinent details: Medication; "Depression", start date: May2000 (unspecified if ongoing), notes: Pertinent details: Medication; "GERD", start date: 1985 (unspecified if ongoing), notes: Pertinent details: Medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch Number: EN6208), administration date: 29Mar2021, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT"; CEREBROSPINAL FLUID LEAKAGE (medically significant), outcome "unknown", described as "CSFL"; IDIOPATHIC INTRACRANIAL HYPERTENSION (medically significant), outcome "not recovered", described as "Idiopathic intracranial hypertension"; HEADACHE (non-serious) with onset 22May2021 19:00, outcome "unknown", described as "get a severe pain above my right ear in my skull". The events "dvt" and "csfl" were evaluated at the emergency room visit. The event "get a severe pain above my right ear in my skull" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) negative; computerised tomogram head: (15Oct2021) unknown result, notes: (narrative); magnetic resonance imaging: (31Aug2021) unknown result, notes: (narrative); magnetic resonance imaging head: (10Oct2021) unknown result; spinal myelogram: (28Sep2021) unknown result, notes: (narrative). Therapeutic measures were taken as a result of idiopathic intracranial hypertension.  Study Result  Impression  1. Moderately motion degraded exam Without acute intracranial abnormality.  2. Mildly expanded partially empty sella and dilated tortuous optic nerve sheaths, Which while nonspecific, can be seen in the setting of idiopathic intracranial hypertension,  3. Minimal presumed chronic small vessel ischemic disease.   Narrative  MRI BRAIN WITHOUT CONTRAST, dated 30Aug2021.  CLINICAL HISTORY: Headache with clear fluid from right nostril, concern for CSF leak.   COMPARISON: CT head Without contrast 30Aug2021 AXial diffusion, T2 FLAIR, susceptibility, T 2 fat sat, and Il-weighted images as well as sagittal TI and  sagittal T2 FLAIR imaging. Due to motion, contrast administration was deferred.   FINDINGS: Examination is moderately degraded by patient motion despit repeat imaging. The diffusion- weighted images are within normal limits. A few bifrontal hemispheric T2 hyperintense white matter foci  and minimal periventricuIarT2 hyperintense foci is nonspecific, but typically attributed to chronic small vessel ischemic disease. No other parenchymal signal abnormality is seen. Sulci are within normal limits for size and configuration for patient age, No extra-axial collection is seen. Major intracranial arterial Structures demonstrate preserved flow voids suggesting patency. Within limitations for motion, no foci of abnormal susceptibility are seen to suggest hemorrhagic breakdown products. Mildly expanded partially empty sella. Midline structures are otherwise within normal limits.   Dilatation of bilateral optic nerve sheaths with tortuosity.   Evaluation for papilledema is limited due to motion. Bilateral lens replacements. Trace right mastoid effusion is redemonstrated. Minimal ethmoid and maxillary sinus mucosal thickening.   Component results There is no component information for this result CT Cervical Spine with Contrast-Details  Study result:  Impression:  There is no convincing evidence of CSF leak in the cervical, thoracic, or lumbar spine.   Degenerative changes are notable for up to moderate spinal canal stenosis at 1.4-1.5 and varying degrees of neural foraminal narrowing in the cervical and lumbar spine as detailed in the body of the report.   Narrative  EXAMS:  1. CT SPINE CERVICAL WITH CONTRAST  2. CT SPINE THORACIC WITH CONTRAST  3. CT SPINE LUMBAR WITH CONTRAST   REASON FOR EXAM:  "eval for site of CSF leak causing IOW pressure headaches; Headache, unspecified"   TECHNIQUE:  Intrathecal contrast was injected via a fluoroscopically aided lumbar puncture (procedure dictated under accession #). After maneuvers to distribute contrast throughout the theca! sac, multiple fluoroscopic captures Were obtained of the cervical, thoracic, and lumbar spine. Helical computed tomographic CT of the cervical, thoracic, lumbar spine was then obtained with construction of multiplanar reformatted image series.   Coparison: None available  Findings:  Cervical spine: The normal cervical lordotic curvature is straightened. There is a chronic fracture  deformity of the superior C7 endplate with up to 40% central height loss and preservation of the anterior  and posterior cortices. The posterior cortex is retropulsed by up to 3 mm. The cervical vertebral body heights are otherwise preserved. There are no suspicious Iytic or sclerotic lesions. There is moderate  intervertebral disc space height loss at C5-C6, C6-C7, and C7-T1. There is no crowding of the foramen magnum or the CI-C2 level. At C2-C3, there is no spinal canal stenosis or neural foraminal stenosis.  At C3-C4, there is mild flattening of the ventral spinal canal, but no significant spinal canal stenosis or neural foramina' stenosis. At C4-CS, the ventral theca' sac is mildly flattened, but there is no spinal canal stenosis or neural foramina' stenosis. At CS-C6,a posterior disc osteophyte complex flattens the ventral  thecal sac but does not cause significant spinal canal stenosis. The left neural foramen is mildly narrowed by uncovertebral hypertrophy. The right neural foramen is patent. At C6-C7, there is no spinal canal stenosis or neural foraminal stenosis. Both facets are mildly degenerated.  At C7-T1, there is no spinal canal stenosis or neural foraminal sten osis. The thoracic spinal cord is normal in caliber.  Small nerve root sleeve diverticula are present on the left at C4-C5 and on the left at C7-TI.   Thoracic spine;  There is focal exaggerated kyphosis at T11-T12 due to an anterior wedge compression deformity of T12 resulting in approximately 30% ventral height loss. The thoracic spine alignment is otherwise normal, and the vertebral body heights are otherwise preserved. A Schmorl node is present in the superior endplate ofT3. The bones are diffusely demineralized. There are no suspicious lytic or sclerotic lesions. There is no significant spinal canal or neural foraminal narrowing at any thoracic level. The thoracic spinal cord is normal in caliber.  Nerve root sleeve filling and small diverticula are present at several thoracic levels. There is no convincing evidence of a CSF-venous fistula. There is no collection of myelographic contrast outside of the theca' sac.   Lumbar spine:  Lumbar lordotic curvature is mildly exaggerated. There is grade retrolisthesis of L2 on L3 with rnoderate to severe intervertebral disc space height loss Of the L2-L3 disc. Sclerotic and cystic endplate changes are present surrounding the L2-L3 intervertebral disc space. The other intervertebral disc space heights are  preserved. The vertebral body heights are preserved. There are no suspicious lytic or sclerotic lesions in the vertebral bodies.  At L1-L2, there is no spinal canal stenosis or neural foraminal stenosis, At L2-L3, a dise bulge, retrolisthesis, and ligamentum flavum thickening result in mild spinal canal stenosis. Both neural foramina are patent.  At L3-L4, there is no spinal canal stenosis of neural foraminal stenosis.  At L4-L5, a disc butge, facet arthropathy, ligamentum flavum thickening result in moderate spinal canal stenosis. The left neural foramen is mildly narrowed. The right neural foramen is patent.  At L5-SI, there 'is no spinal canal stenosis or neural foraminal stenosis.  The conus medullaris terminates at the level of the L2 vertebral body. There is no clumping, thickening, or nodularity of the cauda equina nerve roots.  There is nerve root sleeve filling on the right at T12-LI and bilaterally at L1-L2. There is no definite nerve root sleeve diverticulum at any lumbar level. There is no evidence of CSF-venous fistula. There is no collection of myelographic contrast outside of the thecal sac.   MR Angio Head without Contrast Detail:  Study Result: Impression: No flow seen in the right transverse sinus, but flow is seen in the right sigmoid sinus and internal jugular vein. The flow in the right sigmoid sinus and right internal jugular vein is likely through collaterals. I suspect that the lack of flow in the right transverse sinus is chronic, possibly due to chronic durai sinus thrombosis, allowing formation these collaterals, Signed by MD   Narrative  INDICATION: Headache since 22May2021 with memory changes and hand numbness/tingling. TECHNIQUE: 2D time-of-flight MR venogram of the intracranial venous structures without intravenous contrast. Multiple MIP projections of the vessels of the intracranial circulation were also obtained.   FINDINGS: Flow iS seen in the superior sagittal sinus as well as the left transverse sinus, bilateral sigmoid sinuses, and bilateral internal jugular veins. No flow is seen in the right transverse sinus. Flow is seen in the bilateral internal cerebral veins, vein of Galen, and straight sinus.   CT Head without contrast details: study result: Impression:  1. No acute infarct, hemorrhage or mass effect.  2. No evidence of high-grade stenosis or thrombosis involving the venous system.   Narrative  EXAMINATION:  CT Angiography Head with  contrast, CT Angiography Neck with contrast,  CT Head or Brain without contrast  CLINICAL INDICATION:  r/o VST   TECHNIQUE:  Initial unenhanced head CT was performed as per routine protocol.  After the administration of intravenous contrast, CTV of the head and neck was performed. Post contrast images were obtained after the uneventful intravenous administration of contrast agent.   COMPARISON:  MRI brain without contrast 13Aug2021   FINDINGS:  HEAD CT.  MASS EFFECT & VENTRICLES: No shift. The lateral ventricles are symmetric: The ventricles, sulci and cisterns are normal.  Brain: NO acute infarct, hemorrhage or mass lesion is seen.  Extra-Axial: Extra-axial spaces are normal.  Extra-Cranial: Skull and facial bones are normal. Sinuses and mastoids are clear. Orbits are normal.   HEAD CT THE:  ARTERIES: Visualized portions of the arteries demonstrate no high-grade stenosis or vascular occlusion within the limitations of venous phase timing.  VEINS: No demonstrate venous thrombosis. Dominant left drainage.  Mild stenosis within the distal left transverse sinus. NECK CTV:  Arteries: Visualized portions of the arteries demonstrate no high-grade stenosis or vascular occlusion within the limitations of venous phase timing.  Veins: The IJ veins are patent bilaterally.  Follow-up(21Dec2021): This is a spontaneous follow-up report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included:    Update information included: Patient tab: Patient information, Historical vaccine, Relevant history, Lab data Product tab: Vaccine information Event tab: Event updated  No follow-up attempts are needed. No further information is expected.