Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cardiolipin antibody, Cytomegalovirus viraemia, International normalised ratio, Investigation
Clinical narrative: autoimmune antiphospholipid antibody syndrome; CMV viremia was reactivated by the COVID-19 vaccine; new-onset, progressive tremors in all 4 of his extremities; intermittent fevers that started within 6 days of receiving his second dose of the BNT162b2 mRNA COVID-19 vaccine; This is a literature report.   A 52-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (ongoing); "atrial fibrillation" (unspecified if ongoing); "mechanical aortic and mitral valves implanted" (not ongoing); "mechanical aortic and mitral valves implanted" (not ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for rheumatoid arthritis; GOLIMUMAB subcutaneous taken for rheumatoid arthritis; WARFARIN. Vaccination history included: Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ANTIPHOSPHOLIPID SYNDROME (hospitalization, medically significant, life threatening), outcome "recovered", described as "autoimmune antiphospholipid antibody syndrome"; CYTOMEGALOVIRUS VIRAEMIA (hospitalization, medically significant, life threatening), outcome "recovered", described as "CMV viremia was reactivated by the COVID-19 vaccine"; TREMOR (hospitalization, medically significant, life threatening), outcome "recovered", described as "new-onset, progressive tremors in all 4 of his extremities"; PYREXIA (hospitalization, medically significant), outcome "recovered", described as "intermittent fevers that started within 6 days of receiving his second dose of the BNT162b2 mRNA COVID-19 vaccine". The patient was hospitalized for antiphospholipid syndrome, cytomegalovirus viraemia, tremor, pyrexia (hospitalization duration: 16 day(s)). The events "autoimmune antiphospholipid antibody syndrome", "cmv viremia was reactivated by the covid-19 vaccine", "new-onset, progressive tremors in all 4 of his extremities" and "intermittent fevers that started within 6 days of receiving his second dose of the bnt162b2 mrna covid-19 vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Antibody test: indicated the presence of cytomegalovirus, notes: infection with viremia; Antiphospholipid antibodies: Positive; Negative, notes: 16 days after he was discharged from the hospital; Beta-2 glycoprotein antibody: Positive; Blood culture: negative, notes: for bacterial infection; Body temperature: 102 Fahrenheit, notes: fever; Cardiolipin antibody: Positive; International normalised ratio: did not decrease enough; normalized, notes: enough to reinitiate his warfarin dosing. By Day 2; International normalised ratio (2.5-3.5): more than 8, notes: elevated for mechanical heart valves; less than 1.5, notes: on Day 8; work-up: Hyperreflexia was present in all of his, notes: extremities. broad initial work-up; unremarkable; Lumbar puncture: confirmed the absence of CMV or herpes simplex, notes: virus in his central nervous system on Day 8; Magnetic resonance imaging head: identified a small, acute left-side cerebellar, notes: stroke; Neurological examination: Normal; Polymerase chain reaction: indicated the presence of cytomegalovirus, notes: infection with viremia; Prothrombin time: normalized, notes: enough to reinitiate his warfarin dosing. By Day 2; Prothrombin time (9.7-13.0): more than 90, notes: elevated; Transaminases: elevated; Vital signs measurement: Normal; White blood cell count: leukocytosis. Therapeutic measures were taken as a result of antiphospholipid syndrome, cytomegalovirus viraemia, tremor, pyrexia.  Clinical information : The patient sought care at the emergency department for intermittent fevers that started within 6 days of receiving his second dose of the BNT162b2 mRNA COVID-19 vaccine (Pfizer/BioNTech). After an unremarkable work up, he was discharged home. Six days later, he returned to the emergency department with a fever of 102 Degree F and new onset, progressive tremors in all 4 of his extremities. The patient had a history of rheumatoid arthritis, for which he was taking oral methotrexate 15 mg once weekly and golimumab 50 mg SQ once monthly, and atrial fibrillation. He'd also had mechanical aortic and mitral valves implanted and was taking warfarin (9 mg/d on weekdays, 6 mg/d on Saturday and Sunday). Aside from his fever, his vital signs were normal. He also had horizontal nystagmus (chronically present) and diffuse tremors/myoclonic movements throughout his upper and lower extremities. The tremors were present at rest and worsened with intention/activity, which affected the patient's ability to walk and perform activities of daily living. He was admitted the next day to the family medicine service for further evaluation. Neurology and infectious disease consultations were requested, and a broad initial work up was undertaken. Hyperreflexia was present in all of his extremities, but his neurologic examination was otherwise normal. Initial laboratory tests demonstrated leukocytosis and elevated liver transaminases. His international normalized ratio (INR) and prothrombin time (PT) also were elevated (> 8 [goal, 2.5-3.5 for mechanical heart valves] and > 90 seconds [normal range, 9.7-13.0 seconds], respectively), thus his warfarin was held and oral vitamin K was started (initial dose of 2.5 mg, which was increased to 5 mg when his INR did not decrease enough). By Day 2, his INR and PT had normalized enough to reinitiate his warfarin dosing. Results from the viral antibody and polymerase chain reaction testing indicated the presence of cytomegalovirus (CMV) infection with viremia; blood cultures for bacterial infection were negative. Brain magnetic resonance imaging was ordered and identified a small, acute left-side cerebellar stroke. Lumbar puncture also was ordered but deferred until his INR was below 1.5 (on Day 8), at which point it confirmed the absence of CMV or herpes simplex virus in his central nervous system. The patient started oral valganciclovir 900 mg twice daily to ameliorate his tremors, but he did not tolerate it well, vomiting after dosing. He was switched to IV ganciclovir 5 mg/kg every 12 hours; however, his tremors were not improving, leading the team to suspect an etiology other than viral infection. A presumptive diagnosis of autoimmune movement disorder was made, and serum tests were ordered; the results were positive for antiphospholipid antibodies, including anticardiolipin and anti-ß2 glycoprotein-I antibodies. A final diagnosis of autoimmune antiphospholipid antibody syndrome (APS) related movement disorder1 with coagulopathy was reached, and the patient was started on methylprednisolone 1 g/d IV. They suspected the CMV viremia was reactivated by the COVID-19 vaccine and caused the APS that led to the movement disorder, coagulopathy, and likely, the thrombotic cerebellar stroke. The case was reported to the Vaccine Adverse Event Reporting System (VAERS).; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and events antiphospholipid syndrome, cytomegalovirus viremia and tremor cannot be excluded. Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug bnt162b2, and the event pyrexia cannot be 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.