Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EN6203 | OT / LA |
Dysautonomia; Postural orthostatic tachycardia syndrome; Small fiber neuropathy; Changes in my menstrual cycle with abnormal bleeding; von Willebrand factor high; This is a spontaneous report received from a Consumer or other non HCP. A 34-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EN6203) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression, anxiety. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9267), administration date: 17Mar2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (medically significant), outcome "unknown", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Changes in my menstrual cycle with abnormal bleeding"; VON WILLEBRAND'S FACTOR MULTIMERS ABNORMAL (non-serious), outcome "unknown", described as "von Willebrand factor high". The patient underwent the following laboratory tests and procedures: factor eight assay: (2021) high; Lab work: (unspecified date) Unknown results, notes: Yes a lot of it actually; Von Willebrand's factor antigen test: (2021) high, notes: von Willebrand factor activity is high. Therapeutic measures were taken as a result of autonomic nervous system imbalance. Clinical course: Consumer stated, that she developed the disorder Dysautonomia, Pots postural orthostatic tachycardia syndrome, also developed small fiber neurotherapy and She experienced some changes in menstrual cycle with abnormal bleeding, those she thinks are the most distinguishable right now."Consumer stated, "I am not prior to this but my doctors have put me on IVIG on this and I am also taking Lexapro for anxiety and depression."Consumer stated, "So right now it is finding that I have the factor for von Willebrand, factor is coming back high and if we go back to 2021 I have elevated sedimentation rates. The von Willebrand factor antigen is high, the factor eight assay is high and the von Willebrand factor activity is high."
Medical History/Concurrent Conditions: Anxiety; Depression
LEXAPRO
Test Date: 2021; Test Name: factor eight assay; Result Unstructured Data: Test Result:high; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results; Comments: Yes a lot of it actually; Test Date: 2021; Test Name: von Willebrand factor antigen; Result Unstructured Data: Test Result:high; Comments: von Willebrand factor activity is high.