Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Inappropriate schedule of product administration, Magnetic resonance imaging, Magnetic resonance imaging head, Metastatic neoplasm
Clinical narrative: metastatic disease; Patient Drug Start date: 27OCT2021;10-SEP-2021; This is a spontaneous report received from contactable reporter(s) (Physician and Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 2, single (Lot number: FH8020) at the age of 37 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer 2 stage" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Left breasts cancer", start date: 15Oct2013 (unspecified if ongoing), notes: Bilateral total mastectomy and sentinel lymph node excision with implant reconstruction on 26Nov2013; "2 of 2 lymph nodes were positive with same focus measuribly" (unspecified if ongoing), notes: Receive dose dense AC/T chemotherapy from 16Jan2014 to 23Apr2014; "Low back pain" (unspecified if ongoing); "Metastatic breast carcinoma" (unspecified if ongoing), notes: Metastatic breast carcinoma; "Mid back pain" (unspecified if ongoing), notes: Mid back pain; "Breast neoplasm" (unspecified if ongoing); "Visual disturbance" (unspecified if ongoing); "Never smoker" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FC3183, Location of injection: Arm Right (Right side), Route of administration: Intramuscular), administration date: 10Mar2021, when the patient was 37-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Oct2021, outcome "unknown", described as "Patient Drug Start date: 27OCT2021;10-SEP-2021"; METASTATIC NEOPLASM (medically significant) with onset 04Apr2022, outcome "not recovered", described as "metastatic disease". The event "metastatic disease" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 109/70; Body temperature: (unspecified date) 98.5 Fahrenheit; Computerised tomogram abdomen: (03Nov2017) Tracheobronchial tree; (03Dec2021) Unknown Results, notes: Lymphadenopathy, Nerve issues lytic lesions; Computerised tomogram pelvis: (03Nov2017) Tracheobronchial tree; (03Dec2021) Elevated CEA, notes: Lymphadenopathy, Nerve issues lytic lesions; Computerised tomogram thorax: (03Dec2021) Unknown Results, notes: Worsening bilateral pulmonary modules nerve intra thorasic; (31Oct2016) Stable, notes: Revealed stable pulmonary modules, stable since 2014; Heart rate: (unspecified date) 63; Magnetic resonance imaging: (04Apr2022) Abnormal signal intensity from bone marrow, notes: Extensive widespread intrasective  metastatic disease as compared to CT there has been internal pro of disease; (04Apr2022) Abnormal hypointense T1 and T2 signal from bone ma, notes: Lateral to the insertion of the optic nerve side spread tissues metastatic; Magnetic resonance imaging head: (21Oct2021) Brain tumour (CMS/ HCC), notes: Mild cerebral cortical volume loss is noted above tiny a rich noid cyst in the right middle cranial to ssa(word not ligible); (14Dec2021) Brain tumour (CMS/ HCC), notes: All the level of left orbit there is thickening of retina of the posterior left occular; Ophthalmological examination: (30Nov2021) Negative; Oxygen saturation: (unspecified date) 100 %; physical examinations: (04Dec2017) Well-apperaing; Respiration abnormal: (unspecified date) 19; SARS-CoV-2 test: (25Dec2021) Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of metastatic neoplasm.  Clinical course: Additional information: If other vaccine in four weeks: No. Other medications in two weeks: Center urgent care. If covid prior vaccination: Yes. If covid tested post vaccination: Yes. Covid test post vaccination. Covid test type post vaccination=Nasal Swab,. Covid test date=25Dec2021. Covid test result=Negative. Known allergies: No. According to MRI findings done on 04Apr2022 the patient had a metastatic dwasease, Please see the attached reports for MRI thoracic spine and lumbar spine WO contrast. large lesions in the 2nd sacral segment. Additional involvement was noted at the partially vwasualized posterior portions of the iliac bones. Lumbar vertebrae are normal in height. Alignment was maintained. The conus medullarwas was at level of L1 - L2, lower limits of normal and appears normal in contour and signal. At L1 - L2 , mild loss of dwasc height with mild dwasc osteophyte ridging. Patent spinal canal spinal canal and neural foramina. At L2 - L3 no focal soft dwasc protrusion with patent spinal canal and neural foramina. At L3 - L4 , no focal dwasc protrusion with patent spinal canal and neural foramina. Asymmetric left facet joint degeneration. Mild ligamentous hypertrophy. At L4 - L 5 , diffuse dwasc bulge with right subarticular recesses, right foraminal and right lateral shallow soft dwasc protrusion with mild right foraminal stenoswas and potential right foraminal right L4 root impingement. There was moderate ligamentous hypertrophy and mild facet joint degeneration. Mild to moderate spinal canal stenoswas. At L5 - S1 dwasc bulge with left foraminal and lateral dwasc osteophyte ridging with mild left worse than right facet degeneration. Mild spinal canal stenoswas with mild left foraminal stenoswas. Paravertebral soft twassues are grossly unremarkable. Extensive widespread Intraosseous metastatic dwasease. As compared to the CT, there had been interval progression of dwasease, especially within the sacrum and with interval enlargement of lesion involving the upper portion of L4. Degenerative dwasc dwasease noted including with shallow right subarticular recesses, right foraminal right lateral soft dwasc protrusion L4 - L5 and left lateral dwasc osteophyte complex at L5 - S1. An MRI examination of the lumbar spine was performed on a closed field 3 7 magnet. Sagittal T1 weighted, STIR and T2 weighted sequences as well as axial T1 weighted and 22 weighted sequences. Findings: Extensive sites of abnormal signal intensity from bone marrow noted throughout the vwasualized portion of the axial skeleton, compatible with Intraosseous metastatic dwasease. There was near complete replacement of the body of T11 with depression of superior more inferior endplates and dorsal bulging of the posterior cortex of the vertebral body. No dwascrete epidural soft twassue component was noted at thwas level. Involvement of the body of T12 and left more than right posterior elements, the left-sided posterior elements at L1, extensive involvement of the posterior elements on the left at L2 extension into the dorsal portion of the left side of the vertebral body, with additional involvement deep to the superior endplates on the right. Involvement into the superior endplate of L3. Moderate-sized lesion adjacent to the superior endplate of L4 to the right of midline. Near-complete involvement of the body of L5 with some sparing of the posterior inferior cortex, with approximately 50% loss of height involving the mid and posterior aspects of the superior endplate. Extensive involvement of the upper sacrum with irregular depression of the superior endplate of S1 and greater than right posterior elements at thwas level. Overall heights of the remaining thoracic vertebrae are maintained. There was no focal dwasc herniation or cord impingement. There was no high-grade thoracic spinal canal stenoswas or foraminal narrowing. The thoracic portion of the spinal cord was unremarkable in contour and signal. No edema or syrinx was noted. No abnormal vascularity noted. No epidural collection was seen. IMPRESSION: Widespread osseous metastatic dwasease was noted above. Most extensive involvement of the body of T11 with progression as compared to the prior CT, with involvement of the superior and inferior endplates currently compatible with pathologic fracture with mild depression of the endplates. No dwascrete subjacent epidural soft twassue component was noted. MR THORACIC SPINE NO CONTRAST: 04Apr2022 4: PM. Hwastory: Mid back pain. Breast neoplasm. MRI of the thoracic spine without contrast was performed on a closed field 3 T magnet. Sagittal and axial T1 and T2-weighted series were obtained. Additional sagittal stir series. Comparwason with prior examinations most recently abdominal CT scan Dec2021. Findings: Numerous sites of abnormal hypointense T1 and T2 signal from bone marrow with corresponding STIR hyperintensity, compatible with neoplastic infiltration, noted throughout the axial skeleton, including in multiple vertebral bodies and posterior elements. There was involvement of partially vwasualized inferior portion of body of C6, extensive replacement of C7 as well as the posterior elements, largest lesion in the body of T2 with slight depression of the superior endplate, centrally in the body of T6, within the upper posterior-portion of the left-sided body of T7, in the posterior elements of T10 especially on the left and involving the posterior portion of the left side of the inferior endplate, involving the inferior more than superior endplates of T12. LIVER: Normal in size and contour. No suspicious mass, No steatoswas. Gallbladder: Normal in size and wall thickness. No calcified stones. BILIARY TREE: No Intrahepatic or extrahepatic biliary ductal dilatation. PANGREAS Normal in size. No suspicious mass, SPLEEN: Normal in size. No suspicious mass. ADRENAL GLANDS: No nodularity or thickening. KIDNEYS: Normal in size. No suspicious mass.. No hydronephroswas. URETERS: No hydroureter. BLADDER: Normal In size and wall thickness. REPRODUCTIVE ORGANS: Uterus anteverted in orientation, normal In size, and heterogeneous In appearance. 2.2 om right ovarian rim enhancing corpus luteum. No suspicious adnexal mass, BOWEL: No bowel obstruction. Diffuse gastric wall thickening. PERITONEUM: No ascites. No pneumoperitoneum. VESSELS: Patent and normal in earlier, Mild-atherosclerotic calcification, most pronounced in aortoillac arteries. LYMPH NODES: No suspicious lymphadenopathy. SOFT TWASSUES: No significant hernia. MUSCULOSKELETAL: Several scattered osseous lyto lealons Including: -2.0 cm T11 vertebral body posterior (serios.602, Image 76) -1.5 om L5 vertebral body superior (series 602, Image 70). - 2.0 am L6 vertebral body anterior (series 802, Image 72). -2.2 cm left iliac wing (series 2, image 82). =1,4 cm left femoral head (series 2, Image 107). These are new from 11/3/2017 CT abdomen/pelvwas. In addition, right lateral 8th rib focal bulging/expansion. Final Result. CT CHEST ABDOMEN PELVWAS WIV CONTRAST 03Dec2021 4:18 PM. INDICATION: Hwastory of breast cancer; rwasing tumour markers. TECHNIQUE: CT of the chest, abdomen, and pelvwas with Intravenous contrast was performed in the axial plans with coronal and sagittal reconstructions. 90 ml of intravenous Omni plaque was adminwastered without complication. Oral contrast was adminwastered. COMPARWASON: CT abdomen/pelvwas dated 03Dec2017. CHEST: TRACHEOBRONCHIAL TREE: Patent and normal in caliber. LUNGS: No focal consolidation. Numerous (>100) bilateral pu nodules, scattered throughout all lobes, In somewhat random dwastribution, suspicious for metastases. Most measure <1 om, measure >1 cm. For example, there was a peri vwasceral posterior lobe nodule measuring 1.8 x1.2Cm (secles 5, Image 51). For there was a subpleural lateral right lower lobe nodule measuring om (series 5, Image 79): It was difficult to evaluate for interval eh without prior CT chest at our facility, although lung apices were imaged on 10/22 CT neck and lung bases were partially on 03Dec2017 OT abdomen/pelvwas. However, there were only fe pulmonary nodules seen on these prior studies, nowhere near number of nodules seen on current study. PLEURA: No pleural effusion or pneumothorax. HEART: Normal in size. No pericardial effusion. VESSELS: Patent and normal in caliber. Mild atherosclerotic calcification, most pronounced In coronary arteries. Right upper paratracheal: 1.2 * 1.2om (series 2 1 image 17) THYROID: Vwasualized portions unremarkable. ESOPHAGUS: Hiatal hernia wall thickening. LYMPH NODES: Multiple intra thoracic lymph nodes including: - Right pre vascular: 1.2x1. theta o (series 2 1 Image 16). Right lower pare tracheal: 1.8x1.4 ( cm (series 2, image 22). Right hilar: 2.0 x1.60 (series 2 image 28). Subcarinal: 3.2x2.4 cm (series 2 1 image 28) These are new from 22Oct2019 CT neck. SOFT TWASSUES: Bilateral breast Implants intact. Surgical clips In left axilla and right neck. ABDOMEN/PELVWAS: Reason for Exam H/O BREAST CANCER. Diagnoses Elevated GEA Hwastory of breast cancer. Paranasal sinuses are essentially ulcer. Small ossified left sided nasal + septal spur with adjacent mild turbinate Impingement The mastoid air cells are clear. The vwasualized orbital structures unremarkable. Globes appear symmetric. In configuration. Each lens was in normal anatomic position. No retrobulbar mass. Configuration of the extraocular muscles unremarkable. No abnormal intra-orbital vascularity. Lacrimal apparatus appears unremarkable. No abnormal Intra-orbital enhancement noted in. The calvarium was intact. Orbits appear unremarkable. No abnormal enhancement or compressive mass lesion. Evaluation of brain parenchyma unremarkable. Mild cerebral cortical volume loss was noted above. Tiny arachnoid cyst medially in the right middle cranial fossa without significant mass effect. MR ORBITS BRAIN WAND WO IV CONTRAST:21Oct2021 2:05 PM. Hwastory: Hwastory of breast Tumour, left sided pain and vwasual dwasturbances. Description: MRI of the brain with attention to the orbits was performed, with IV contrast. T1, coronal T2, axial T1,T2, axial and sagittal FLAIR and diffusion-weighted sequences of the head with dedicated high resolution axial and coronal sequences through the orbits were performed, followed by postcontrast dedicated Images of the orbits and axial Imaging of the brain. 15 mi of Dotarem was injected. Comparwason with prior MRI brain July performed 2019. Mild cortical volume loss in the biparietal regions. Small arachnold cyst measuring approximately 1 cm in greatest dimension noted adjacent to the anteromedial portion of the right temporal lobe. Remaining cerebral ventricles, basal cwasterns and cortical sulct are age-appropriate. No hydrocephalus or extra-axlal fluid collection. No focal intraparenchymal lesion was noted. No acute mass effect or midline shift. No restricted diffusion to suggest acute waschemia. No abnormal enhancement was noted. The major Intracranial arterial and dural venous sinus flow-voids are grossly preserved. Dominant right vertebral artery and left transverse sinus, reflecting normal variation. Subtle irregularity of the juxta clinoid/ proximal supraclinold segment of the left ICA possibly partial volume averaging. Skull base grossly unremarkable. Pneumatization left anterior clinoid process, normal variant. The sella and suprasellar regions are grossly unremarkable. Skull base appears intact. No Chiari malformation. Reason for Exam Brain mass or lesion. MRI Scan of the Brain (with and without intravenous contrast): The examination was performed in multiple planes utilizing multiple pulse sequences both before and after the adminwastration of intravenous contrast. There are no previous imaging tests or test results available for correlation. The submitted clinical information was hwastory of breast cancer with present problems with the left eye. The examination demonstrates the ventricles to be normal in position and appearance. No cortical atrophy was seen. There was no hemorrhage, infarct, mass, or demyelinating dwasease. The IAC nerve complexes are vwasualized, symmetric and normal in appearance. Normal vascular flow voids are seen along the base of the skull on both sides. No CP angle mass lesion was on either side. The pituitary gland was not enlarged. The brainstem, the posterior fossa, the cervicomedullary junction, and the pineal gland are unremarkable. The gradient echo images reveal no hemorrhage. On the diffusion weighted images, there was no evidence of a recent waschemic event. The right orbit and its contents are unremarkable. At the level of the left orbit, there was thickening of the retina of the posterior left ocular globe lateral to the insertion of the optic nerve. The extra-ocular muscles and optic nerve appear unremarkable on both sides. The paranasal sinuses and the mastoid regions are clear. Following intravenous contrast adminwastration, there was no abnormal enhancement at any intracranial level. There was no abnormal enhancement at the level of either ocular nerve or the left ocular globe. An ophthalmological evaluation was recommended. Impression: No intracranial abnormality seen. No abnormal intracranial enhancement following intravenous contrast adminwastration. Thickening of the retina of the posterior left ocular globe lateral to the optic nerve demonstrating no enhancement following intravenous contrast adminwastration. An ophthalmological evaluation was recommended.  No follow-up attempts are possible. No further information was expected.  Follow up(26Apr2022): Their was was a follow up spontaneous report from a contactable nurse. Thwas nurse reported for 37-year-old female (patient) in response to HCP letter sent via follow-up letter which included that: Updated information: Primary reporter salutation added in slider#01, Email address and Department added in slider#02 reporter, New reporter added in slider#03, 04,05,06,07,08,09, In hwastorical vaccine first dose Lot No and route added in notes field, RMH added, Laboratory results performed on various dates added, For suspect product Lot No and route added, Best doctor field added, Vaccination facility name added, New event "Metastatic dwasease" added. Conmed therapy added as none.  No follow-up attempts are possible. No further information was expected.