Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chronic inflammatory demyelinating polyradiculoneuropathy, Demyelinating polyneuropathy, Depression, Electromyogram
Clinical narrative: He was hospitalized in Mar2022 with abdominal pain and sepsis; He was hospitalized in Mar2022 with abdominal pain and sepsis; Increased stress; Increased joint pain; deconditioning; was diagnosed with Beil's palsy; bilateral median neuropathy; CIDP (chronic inflammatorydemyelinating polyneuropathy); sensorimotor polyneuropathy with demyelinating features; sensorimotor polyneuropathy with demyelinating features; generalized weakness; fatigue; bilateral facial weakness; B12 deficiency; Depression; Gout; Hypertension; Iron deficiency anemia; Severe obesity; This is a spontaneous report received from a Physician, Program ID.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAEMIA VITAMIN B12 DEFICIENCY (non-serious) with onset Apr2021, outcome "unknown", described as "B12 deficiency"; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant) with onset Apr2021, outcome "unknown", described as "CIDP (chronic inflammatorydemyelinating polyneuropathy)"; DEPRESSION (non-serious) with onset Apr2021, outcome "unknown"; GOUT (non-serious) with onset Apr2021, outcome "unknown"; HYPERTENSION (non-serious) with onset Apr2021, outcome "unknown"; IRON DEFICIENCY ANAEMIA (non-serious) with onset Apr2021, outcome "unknown", described as "Iron deficiency anemia"; OBESITY (non-serious) with onset Apr2021, outcome "unknown", described as "Severe obesity"; FACIAL PARESIS (non-serious) with onset Apr2021, outcome "unknown", described as "bilateral facial weakness"; NEUROPATHY PERIPHERAL (medically significant) with onset Apr2021, outcome "unknown", described as "bilateral median neuropathy"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered"; ASTHENIA (non-serious) with onset Apr2021, outcome "not recovered", described as "generalized weakness"; DEMYELINATING POLYNEUROPATHY (medically significant), PERIPHERAL SENSORIMOTOR NEUROPATHY (non-serious) all with onset Apr2021, outcome "unknown" and all described as "sensorimotor polyneuropathy with demyelinating features"; BELL'S PALSY (medically significant) with onset Apr2021, outcome "unknown", described as "was diagnosed with Beil's palsy"; SEPSIS (hospitalization), ABDOMINAL PAIN (hospitalization) all with onset Mar2022, outcome "unknown" and all described as "He was hospitalized in Mar2022 with abdominal pain and sepsis"; STRESS (non-serious), outcome "unknown", described as "Increased stress"; ARTHRALGIA (non-serious), outcome "unknown", described as "Increased joint pain"; PHYSICAL DECONDITIONING (non-serious), outcome "unknown", described as "deconditioning". The patient was hospitalized for sepsis, abdominal pain (start date: 2022). The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (unspecified date) 0.94; Electromyogram: (unspecified date) Unknown results; (03Sep2021) bilateral median neuropathy, notes: bilateral median neuropathy as well as a sensorimotor polyneuropathy with demyelinating features; Electrophoresis protein: (unspecified date) Unknown results, notes: SPEP without monoclonal gammopathy; Glycosylated haemoglobin: (unspecified date) 5.5 %; AChR: (unspecified date) Negative, notes: negative AChR and MuSK antibodies/Testing for myasthenia gravis was negative; (unspecified date) 936; (unspecified date) Negative, notes: negative AChR and MuSK antibodies. Therapeutic measures were taken as a result of bell's palsy, chronic inflammatory demyelinating polyradiculoneuropathy. The patient returns to neurology clinic for followup of CIDP. He was last seen on 29Mar2024. "Briefly, symptoms began In late Apr2021 after the patient received COVID-19 vaccination. The experienced generalized weakness, fatigue, and bilateral facial weakness. He initially presented to an outside hospital and was diagnosed with Beil's palsy and started on a prednisone taper. EMG performed on 03Sep2021 showed bilateral median neuropathy as well as a sensorimotor polyneuropathy with demyelinating features. He was hospitalized in Mar2022 with abdominal pain and sepsis. Repeat EMG was performed at (withheld). After his initial visit in Jan2023 he was started on IVIG once monthly. He initially noticed improvement but felt that the IVIG was wearing off too quickly. His dose was increased every 2 weeks." He is also on prednisone 20 mg daily. At his last visit he described worsening weakness and fatigue. Following his last visit laboratory studies revealed A1c of 5.5%, TSH of 0.94, B12 936, SPEP without monoclonal gammopathy, and negative AChR and MuSK antibodies. He had been feeling better until recently. He describes increased stress after the death of his mother. He was responsible for managing her funeral. He feels symptoms may be related to stress. He also describes Increased joint pain, which he attributes to weather changes. Assessment/ Plan: The patient is a 59-year-old male who returns to neurology clinic for follow up of CIDP. He is currently on IVIG every 2 weeks and prednisone 20 mg daily. He feels that symptoms have been worse. Testing for myasthenia gravis was negative. They discussed potentially transitioning to Hytrulo. He attributes his recent increase in symptoms to life stressors and would prefer to hold off on medication changes at this time. His weight gain and deconditioning may also be playing a role in his fatigue. Chronic Problem List: B12 deficiency, CIDP (chronic inflammatory demyelinating polyneuropathy), Depression Gout, Hypertension, Iron deficiency anemia, Severe obesity.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is a reasonable possibility that the events Bell's palsy, facial paresis, asthenia, and fatigue were related to BNT162b2 based on known drug safety profile. The association between the events sepsis, abdominal pain, peripheral neuropathy, CIDP, and demyelinating polyneuropathy with BNT162b2 can not be fully excluded based on the limited 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.