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This is VAERS ID 1796149

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First Appeared on 10/22/2021

VAERS ID: 1796149
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:2021-07-27
Onset:2021-08-18
Submitted:0000-00-00
Entered:2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 LA / OT

Administered by: Other      Purchased by: ??
Symptoms: Anaplastic thyroid cancer, Blood calcitonin, Blood calcium, Blood thyroid stimulating hormone, C-reactive protein, Computerised tomogram, Condition aggravated, Haemoglobin, Immunoglobulins, Lymphocyte count, Oxygen saturation, Platelet count, Thyroxine, Tri-iodothyronine, White blood cell count, Ultrasound thyroid, Epstein-Barr virus test, Toxoplasma serology, Ear, nose and throat examination, Anti-thyroid antibody, Cytomegalovirus test, Investigation, Thyroidectomy, Bacterial test, Thyroid stimulating immunoglobulin, Diagnostic aspiration

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-09-24
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: OESTRODOSE; PROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; COVID-19; Menopause; Thyroid nodule (EU-TIRADS 4)
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: anti-TG Antibody; Result Unstructured Data: Test Result:no anti-TG Antibody; Test Date: 20210823; Test Name: anti-TPO; Result Unstructured Data: Test Result:no anti-TPO Antibody; Test Date: 20210908; Test Name: anti-TPO; Test Result: Negative ; Test Date: 2021; Test Name: pulmonary infection; Result Unstructured Data: Test Result:Staph. Aureus; Test Date: 2021; Test Name: urinary tract infection; Result Unstructured Data: Test Result:Proteus Mirabilis; Test Date: 20210908; Test Name: calcitonin; Test Result: Negative ; Test Date: 20210908; Test Name: Ca; Result Unstructured Data: Test Result:2.52 mmol/L; Test Date: 20210819; Test Name: TSH; Result Unstructured Data: Test Result:13.13 MiU/L; Test Date: 20210823; Test Name: TSH; Result Unstructured Data: Test Result:normal MiU/L; Test Date: 20210823; Test Name: CT; Result Unstructured Data: Test Result:hematocele of the left macronodule; Comments: hematocele of the left macronodule, with mass effect, suspicious aspect of high grade tumor. Small supra-isthmic nodule, hypodense, possibly infectious. Subcentimetric reactive polyadenopathy. Non-obstructive focal thrombosis, infracentimetric left internal jugular; Test Date: 20210909; Test Name: CT; Result Unstructured Data: Test Result:heteromulti nodular thyroid; Comments: heteromulti nodular thyroid with bilateral cervical adenopathies, and left jugular thrombosis extended over 14 cm. Multiple pulmonary nodular lesions suspicious of secondary lesions.; Test Date: 20210921; Test Name: CT; Result Unstructured Data: Test Result:Global extension of the different tumor lesions; Comments: especially cervical adenopathies, and secondary pulmonary lesions. Progression of the thrombosis of the left internal jugular vein extended intracranially to the left transverse sinus as well as the appearance of a thrombosis of the right internal jugular vein and a non-obstructive thrombosis of the left brachiocephalic venous trunk and a necrotic collection per tracheo-esophageal.; Test Date: 20210823; Test Name: CT scan; Result Unstructured Data: Test Result:suspicious aspect of high grade tumor; Test Date: 20210819; Test Name: CRP; Result Unstructured Data: Test Result:42.5 mg/l; Test Date: 20210823; Test Name: CRP; Result Unstructured Data: Test Result:112.5 mg/l; Test Date: 20210819; Test Name: CMV serology; Result Unstructured Data: Test Result:in favor of an old infection; Test Date: 20151013; Test Name: Fine needle aspiration; Result Unstructured Data: Test Result:Possible lymphocytic thyroiditis; Comments: vesicular lesion of benign significance. Possible lymphocytic thyroiditis.; Test Date: 2021; Test Name: Fine needle aspiration; Result Unstructured Data: Test Result:suggestive of a partially necrotic carcinoma; Test Date: 20210823; Test Name: Fine needle aspiration; Result Unstructured Data: Test Result:suggestive of a partially necrotic carcinoma; Test Date: 20210909; Test Name: ENT consultation; Result Unstructured Data: Test Result:paralysis of the left vocal cord; Comments: at nasofibroscopy a paralysis of the left vocal cord in intermediate position.; Test Date: 20210819; Test Name: EBV serology; Result Unstructured Data: Test Result:in favor of an old infection; Test Date: 20210819; Test Name: Hb; Result Unstructured Data: Test Result:129 g/l; Test Date: 20210908; Test Name: serum Ig; Result Unstructured Data: Test Result:Normal; Test Date: 20210819; Test Name: PNN; Result Unstructured Data: Test Result:7.41 x10 9/l; Test Date: 20210819; Test Name: lymphocytes; Result Unstructured Data: Test Result:2.45 x10 9/l; Test Date: 20210913; Test Name: desaturation; Result Unstructured Data: Test Result:desaturation; Comments: desaturation at the slightest effort; Test Date: 20210819; Test Name: platelets; Result Unstructured Data: Test Result:300 x10 9/l; Test Date: 20210908; Test Name: Anti-TSH receptor antibodies; Test Result: Negative ; Test Date: 20210915; Test Name: Total thyroidectomy; Result Unstructured Data: Test Result:Undifferentiated carcinoma; Comments: Undifferentiated carcinoma, occupying the whole thyroid (more than 10 cm), developed on a very minor (5%) poorly differentiated contingent, with extrathyroidal extension to the striated muscle, to the adipose tissue, infiltrating the recurrent nerve, reaching largely the limits of posterior resection, with multiple vascular emboli notably in the left jugular vein. No BRAF mutation on immunohistochemistry. Central removal: 3N+/10N; Test Date: 20210823; Test Name: T4; Result Unstructured Data: Test Result:normal; Test Date: 20210819; Test Name: toxoplasmosis serology; Result Unstructured Data: Test Result:in favor of an old infection; Test Date: 20210823; Test Name: T3; Result Unstructured Data: Test Result:normal; Test Date: 2015; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:lower thyroid volume than 15Jun2021; Comments: slight increase in thyroid volume since last checkup performed in 2015; Test Date: 20151013; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:left thyroid lobe nodule; Comments: 24.5mmx33.5mmx22.1mm left thyroid lobe nodule, mixed echostructure with predominantly solid.; Test Date: 20210615; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:increase in thyroid volume; Comments: slight increase in thyroid volume since last checkup performed in 2015. Progressive EU-TIRADS 4 macronodule measured at 30.4 x 28.7 x 40.3mm; Test Date: 20210830; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:relative stability of the left thyroid nodule; Comments: relative stability of the left thyroid nodule compared to previous ultrasounds. Modification of the para-isthmic region and of the right lobe with nodular elements of recent appearance of identical echostructure to the left nodule.; Test Date: 20210819; Test Name: WBC; Result Unstructured Data: Test Result:13 x10 9/l; Test Date: 20210823; Test Name: WBC; Result Unstructured Data: Test Result:18 x10 9/l
CDC 'Split Type': FRPFIZER INC202101356423

Write-up: Anaplastic thyroid cancer; Disease aggravation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY202111492. A 45-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 27Jul2021 (Lot Number: FF0680) as dose 1, single for Covid-19 immunisation. Medical history included menopause from 2019, Covid-19 from 15Apr2019, cholecystectomy from Feb2020, thyroid mass (EU-TIRADS 4) from 2015. Concomitant medications included estradiol (OESTRODOSE) taken for an unspecified indication, start and stop date were not reported; progesterone (PROGESTERONE) taken for an unspecified indication, start and stop date were not reported. The patient experienced anaplastic thyroid cancer (anaplastic thyroid cancer) (death, hospitalization) on 18Aug2021, disease aggravation (condition aggravated) (death, hospitalization) on 18Aug2021. The patient''s thyroid monitoring not performed since 2015. On 15Jun2021, Her primary care physician resumed follow-up. Thyroid ultrasound: slight increase in thyroid volume since last checkup performed in 2015. - 27Jul2021 - First dose of COMIRNATY vaccine in IM in the left arm (lot number FF0680). - 29Jul2021 - Patient comes in for consultation and was asymptomatic. - 18Aug2021 - Appearance of a voluminous anterior cervical swelling, cervical and supra-clavicular adenopathies. - 23Aug2021 - Hospitalization in this context. On clinical examination: tense neck, no erythema opposite, tender. A CT scan shows a suspicious aspect of high grade tumor. A Fine needle aspiration was suggestive of a partially necrotic carcinoma. Partial improvement under antibiotic therapy, return home the next day.- 09Sep2021 - ENT consultation which found at nasofibroscopy a paralysis of the left vocal cord in intermediate position.- 13Sep2021 - The patient was admitted to hospital with a large goitre and increased dyspnoea with the appearance of stridor, desaturation at the slightest effort, leading to an emergency surgical indication.- 15Sep2021 - Total thyroidectomy this day. BIOLOGY: - 19Aug2021 - Hb 129g/L, WBC 13G/L, PNN 7.41G/L, lymphocytes 2.45G/L, platelets 300G/L, CRP 42.5mg/L, TSH 13.13mUI/L, EBV, CMV and toxoplasmosis serologies in favor of an old infection.- 23Aug2021 - WBC 18G/L, CRP 112.5mg/L, TSH, T4 and T3 normal, no anti-TPO Antibody, no anti-TG Antibody- 08Sep2021 - Anti-TPO, Anti-TSH receptor antibodies and calcitonin negative, Ca 2.52 mmol/L, serum Ig Normal. COMPLEMENTARY EXAMINATION: - 13Oct2015 - Thyroid ultrasound: 24.5mmx33.5mmx22.1mm left thyroid lobe nodule, mixed echostructure with predominantly solid. Fine needle aspiration: vesicular lesion of benign significance. Possible lymphocytic thyroiditis.- 15Jun2021 - Thyroid ultrasound: Progressive EU-TIRADS 4 macronodule measured at 30.4 x 28.7 x 40.3mm. - 23Aug2021 - CT: hematocele of the left macronodule, with mass effect, suspicious aspect of high grade tumor. Small supra-isthmic nodule, hypodense, possibly infectious. Subcentimetric reactive polyadenopathy. Non-obstructive focal thrombosis, infracentimetric left internal jugular. Fine needle aspiration: suggestive of a partially necrotic carcinoma. - 30Aug2021 - Thyroid ultrasound: relative stability of the left thyroid nodule compared to previous ultrasounds. Modification of the para-isthmic region and of the right lobe with nodular elements of recent appearance of identical echostructure to the left nodule. - 09Sep2021 - CT: heteromulti nodular thyroid with bilateral cervical adenopathies, and left jugular thrombosis extended over 14 cm. Multiple pulmonary nodular lesions suspicious of secondary lesions.- 15Sep2021 - Total thyroidectomy: Undifferentiated carcinoma, occupying the whole thyroid (more than 10 cm), developed on a very minor (5%) poorly differentiated contingent, with extrathyroidal extension to the striated muscle, to the adipose tissue, infiltrating the recurrent nerve, reaching largely the limits of posterior resection, with multiple vascular emboli notably in the left jugular vein. No BRAF mutation on immunohistochemistry. Central removal: 3N+/10N. left sector II and V adenopathies: metastatic lymph node conglomerate of 3.5 cm long axis - left sector IIA adenopathies: 1N+/1N. - 21Sep2021 - CT: Global extension of the different tumor lesions, especially cervical adenopathies, and secondary pulmonary lesions. Progression of the thrombosis of the left internal jugular vein extended intracranially to the left transverse sinus as well as the appearance of a thrombosis of the right internal jugular vein and a non-obstructive thrombosis of the left brachiocephalic venous trunk and a necrotic collection per tracheo-esophageal. EVOLUTION: - Following thyroidectomy: maintenance of sedation with Propofol/Sufentanyl then Propofol/Remifentanyl. A decrease in corticosteroids is started. Cefazoline was introduced in the face of a pulmonary infection (Staph. Aureus), as well as a urinary tract infection with Proteus Mirabilis. Unfavorable local clinical evolution with a neck becoming more and more edematous, indurated, with skin hematoma and slight. - Reoperation in the operating room confirming the tumor extension with transglottic involvement and involvement of the right vocal cord, thus realizing a paralysis of the two vocal cords in adduction. No cordotomy procedure can therefore be performed.The patient died on 24Sep2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Anaplastic thyroid cancer; Disease aggravation

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