Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Acute Transverse Myelitis; This is a literature report.  A 79 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURE UNKNOWN, DOSE 1, lot number unknown), for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (hospitalization), outcome "recovering", described as "Acute Transverse Myelitis". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: increased signal intensity extending from c4 to c6, notes: -C7. Therapeutic measures were taken as a result of myelitis transverse. Clinical course and discussion is as follows: A 79-year-old woman presented to the hospital with a complaint of bilateral upper extremity weakness. She had recently received the second dose of the COVID-19 vaccine two and a half weeks prior to the onset of her symptoms. The patient underwent MRI imaging of her brain and cervical spine which revealed increased signal intensity extending from C4 to C6-C7. The patient was evaluated by neurology and determined to have transverse myelitis. Setting: Inpatient rehabilitation facility. Assessment/Results: The patient underwent treatment with intravenous methylprednisolone and her condition began to improve. She was transitioned to an oral steroid taper and did not require intravenous immunoglobulin or plasma exchange. She was admitted to our acute rehabilitation acility where she was found to need moderate assistance for transfers and minimal assistance for ambulation. She also required moderate to total assistance for dressing. Discussion: Transverse myelitis has been associated with certain viral illnesses. More rarely, it has been seen following certain vaccinations. This unique case is particularly important as it demonstrates a possible link between transverse myelitis and the COVID-19 vaccine. This case was therefore reported to the FDA. At least one other case of transverse myelitis has been reported as an adverse event linked to receiving a COVID-19 booster vaccine during the vaccine trials. There are currently multiple vaccines against COVID-19 being used which have been FDA approved and are currently undergoing phase 4 trials. Therefore, healthcare professionals must continue to observe for possible adverse events associated with the vaccine. Conclusion: While there is currently insufficient data to form a direct association between the COVID-19 vaccine and transverse myelitis, it is vitally important for healthcare professionals to remain vigilant for potential adverse events and report them to the FDA as appropriate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship and lack of an alternative etiology, the association between the event acute transverse myelitis with BNT162b2 can not 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.