Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Full blood count, HIV test, Investigation, Laboratory test
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a literature report for the following literature source(s): A 28-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, in Dec2021 as unk, single. The following information was reported: DRUG INEFFECTIVE (medically significant, life threatening), COVID-19 (medically significant, life threatening) all with onset Mar2022, outcome "recovered" (Mar2022) and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: Anti-aquaporin-4 antibody: (2022) Negative, notes: tested twice by cell-based assay; Antibody test: (2022) Negative, notes: tested twice. by cell-based assay; Antineutrophil cytoplasmic antibody: (2022) Negative; Antinuclear antibody: (2022) Negative; Biopsy spinal cord: (Aug2022) Pathology confirmed a diffuse midline glioma, notes: H3 K27M-mutant, WHO. grade 4; Computerised tomogram abdomen: (2022) showed no evidence, notes: of sarcoidosis or suspicious masses; Computerised tomogram pelvis: (2022) showed no evidence, notes: of sarcoidosis or suspicious masses; Computerised tomogram thorax: (2022) showed no evidence, notes: of sarcoidosis or suspicious masses; CSF culture: (2022) Negative; CSF glucose: (2022) normal; CSF protein: (2022) normal; CSF test: (2022) 3 white blood cells and, notes: normal protein and glucose levels; CSF white blood cell count: (2022) 3; Cytology: (2022) Negative; Full blood count: (2022) unremarkable; HIV test: (2022) Negative; screen for Lyme disease: (2022) Negative; venereal disease research laboratory test: (2022) Negative; Magnetic resonance imaging head: (2022) normal; Magnetic resonance imaging spinal: (unspecified date) persistent enhancement, notes: of the cervical cord lesion; (2022) an enhancing, expansile T2-hyperintense lateral, notes: lesion from C3-C6, as well as what appeared to be a second nonenhancing lesion in the left aspect of the thoracic cord from T2-T4; Metabolic function test: (2022) unremarkable; Neurological examination: (unspecified date) significant 1/5 weakness in, notes: her left deltoid, wrist flexors, wrist extensors, and intrinsic muscles of the left hand as well as 0/5 weakness in her left biceps and triceps. She had 4/5 weakness throughout her right arm and left leg and nearly preserved 5-/5 strength in her right leg; (May2022) mild 4/5 weakness in the extensor muscles, notes: of her left arm and proximal left leg but normal tone throughout. Sensation was intact to pinprick and vibration in her distal extremities bilaterally. Reflexes were more brisk on her left side compared with her right side; (2022) 3/5 strength throughout her left upper extremity; Oligoclonal band assay: (2022) No; Red blood cell sedimentation rate (0-30): (2022) 99, notes: unit: mm/h elevated; Treponema test: (2022) Negative; Viral test: (2022) Negative; Vitamin B12: (2022) normal. Case report: A 28-year-old previously healthy woman presented with 7-8 months of progressive left-sided weakness and right-sided paresthesias. Her symptoms started in October 2021 when she noticed mild weakness in her left arm as well as numbness and tingling in her right arm and leg shortly after a nonspecific mild upper respiratory infection. Her symptoms resolved spontaneously in several weeks, and she did not seek medical attention. In December 2021, she received simultaneous coronavirus disease 2019 (COVID-19) mRNA booster and influenza vaccines and noted some return of left arm stiffness. In late March 2022, after she recovered from a mild COVID-19 infection, she noticed progressive worsening of her left-sided weakness (arm worse than leg) and right-sided paresthesias. She saw a neurologist in May 2022 where her neurologic examination demonstrated mild 4/5weakness in the extensor muscles of her left arm and proximal left leg but normal tone throughout. Sensation was intact to pinprick and vibration in her distal extremities bilaterally. Reflexes were more brisk on her left side compared withher right side. Her MRI of the brain was normal, but MRI of the spine revealed an enhancing, expansile T2-hyperintense lateral lesion from C3-C6, as well as what appeared to be a second nonenhancing lesion in the left aspect of the thoracic cord from T2-T4 (Figure 2). She was admitted to the hospital where laboratory evaluation yielded an unremarkable comprehensive metabolic panel and complete blood count, an elevated erythrocyte sedimentation rate of 99 mm/h (normal range 0-30 mm/h), a normal vitamin B12 level, negative antinuclear antibody (ANA) and antineutrophilcytoplasmic antibodies tests, and negative screens for syphilis, HIV, and Lyme disease. Serum myelin oligodendrocyte glycoprotein (MOG) and aquaporin-4 (AQP4) antibody tests were negative by cell-based assay (tested twice). CSF showed 3 white blood cells and normal protein and glucose levels. There were no oligoclonal bands. CSF cultures, venereal disease research laboratory test (VDRL), viral studies, and cytology for malignant cells were negative. A CT scan of the chest, abdomen, and pelvis was performed and showed no evidence of sarcoidosis or suspicious masses.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect products COVID-19 Vaccine - Manufacturer Unknown, and BNT162B2 cannot be fully excluded. 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-PV202400145083 Same article/drug/event/patient; different dose.;