Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Muscular weakness, Paraesthesia
Clinical narrative: CIDP; falling; numbness and tingling in my extremities; numbness and tingling in my extremities; muscle weakness; fatigue; This is a spontaneous report received from a Nurse.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2021 as dose 2, single (Lot number: EW0170) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Anxiety/Depression" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ultram, reaction(s): "Known allergies: Ultram"; Bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch\Lot number: ER8733, Anatomical location: Right Arm), administration date: 02Apr2021, when the patient was 50-year-old, for COVID-19 immunisation. The following information was reported: FALL (disability) with onset 28Oct2021, outcome "not recovered", described as "falling"; FATIGUE (disability) with onset 28Oct2021, outcome "not recovered"; MUSCULAR WEAKNESS (disability) with onset 28Oct2021, outcome "not recovered", described as "muscle weakness"; HYPOAESTHESIA (disability), PARAESTHESIA (disability) all with onset 28Oct2021, outcome "not recovered" and all described as "numbness and tingling in my extremities"; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (disability) with onset Feb2022, outcome "not recovered", described as "CIDP". The patient underwent the following laboratory tests and procedures: Electromyogram: (Feb2022) CIDP; nerve conduction study: (Feb2022) CIDP. Therapeutic measures were taken as a result of fall, hypoaesthesia, paraesthesia, muscular weakness, fatigue, chronic inflammatory demyelinating polyradiculoneuropathy which included Azathioprine. Clinical course: Six months after taking the vaccine she had issues with falling, numbness and tingling in her extremities, muscle weakness and fatigue. In Feb2022 a nerve conduction study and EMG showed that I had CIDP and I am still continuing treatment. Patient was not administered with any other vaccine on same date or in four weeks and it is unknown if any other medication was given in two weeks.; Sender's Comments: Based on the available information and the known drug safety profile and temporal relationship , the event Hypoaesthesia, Paraesthesia and Fatigue assessed related to the suspect drug. Based on the available information and the temporal relationship , the relationship between the events Fall, Muscular weakness and suspect drug cannot be excluded. Based on the available information and the relationship  event Chronic Inflammatory demyelinating polyradiculopathy  and suspect drug cannot be excluded considering neurological  adverse events Hypoaesthesia, Paraesthesia are expected. 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.