Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Hemiplegia, Joint range of motion decreased, Livedo reticularis
Clinical narrative: Right sided paralysis; Mottled skin; Joint range of motion decreased; Short-term memory loss; Headache; This is a Solicited report from FACILITATED COLLECT based on the information received by Pfizer manufacture number (21K-163-4088291-00).  A contactable consumer (patient) reported that a 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 150 mg (1 in 12 Wk) for psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced right sided paralysis, mottled skin, joint range of motion decreased, short-term memory loss, headache, all on an unspecified date. The action taken in response to the events for risankizumab was unknown. The outcome of headache was not recovered, the rest events was unknown. All events were resulted in physician office visit. Solicited report by a consumer of an adult female with events of  right side paralysis and non-serious mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache with SKYRIZI (RISANKIZUMAB). There was no reported medical history. On unknown dates, the patient experienced right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had a severe reaction of right side paralysis, mottled skin knees upward, unable to lift head, unrelieved head ache to Pfizer covid vaccine. She was under care of a neurologist, headache has never gone away. She had short term memory loss. She pending an electroencephalogram 81 magnetic resonance imaging. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache was not provided. Opinion is that there is no reasonable possibility that the events of right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache are related to SKYRIZI(RISANKIZUMAB). Causality for BNT162B2: the reporter's causality for all events was not provided.   The reporter's assessment of the causal relationship of all events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The information provided is very limited and does not allow a meaningful medical assessment of the case. Patient's medical history, lab investigations, diagnostic procedures, concomitant medications, treatment aspects etc would have allowed better to assess the case. However, based on the available information and considering drug event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of right sided paralysis, mottled skin, joint range of motion decreased, short-term memory loss and headache. The case will be reassessed further upon receipt of additional information.  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.