Age: 66.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Muscular weakness, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), 0.3 ml single (Lot number: GH9693) at the age of 66 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "penicillins" (unspecified if ongoing), notes: is allergic to penicillins and lisinopril.; "MS" (unspecified if ongoing), notes: The patient is followed in the neurology clinic with a diagnosis of MS and RLS.; "Urinary tract infection without hematuria" (unspecified if ongoing), notes: Urinary tract infection without hematuria; "RLS" (unspecified if ongoing), notes: The patient is followed in the neurology clinic with a diagnosis of MS and RLS. The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "allergic to lisinopril", notes: is allergic to penicillins and lisinopril. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE , Lot#: EL9264), administration date: 30Jan2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "COVID 19", "COVID 19"; BNT162b2 (DOSE 2, 0.3 ML SINGLE , Lot# EN6200), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Route: IM, Site: Deltoid L , Manufacturer: Pfizer, Lot# FF8841), administration date: 27Sep2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), 0.3 ML SINGLE, Route: IM , Site: Deltoid L , Manufacturer: Pfizer, Lot#: FK9895), administration date: 31Mar2022, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19". The following information was reported: GAIT INABILITY (disability), outcome "not recovered", described as "She can walk 5-10 feet in her house, but then she starts having starts having spasms"; ILLNESS (non-serious), outcome "not recovered", described as "sick"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue/her hand needs to be in a particular position, otherwise it feels like a strain"; NAUSEA (non-serious), outcome "not recovered", described as "nauseous"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "her neck and back feel weak. "; SENSORY LOSS (non-serious), outcome "not recovered", described as "she does not have good sensation in her legs"; DYSARTHRIA (non-serious), outcome "not recovered", described as "She states that talking and singing are difficult for her now"; CONTUSION (non-serious), outcome "not recovered", described as "her arm gets bruised". The events "she can walk 5-10 feet in her house, but then she starts having starts having spasms", "sick", "fatigue/her hand needs to be in a particular position, otherwise it feels like a strain", "nauseous", "her neck and back feel weak", "she does not have good sensation in her legs", "she states that talking and singing are difficult for her now" and "her arm gets bruised" required physician office visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (12-63): (20Dec2021) 52, notes: U/L; Aspartate aminotransferase (0-37): (20Dec2021) 32, notes: U/L; Basophil count (0.0-0.2): (20Dec2021) 0.0, notes: K/uL; Basophil count: (20Dec2021) 0.0 %; Blood albumin (3.2-4.7): (20Dec2021) 3.7 g/dl; Blood alkaline phosphatase (26-137): (20Dec2021) 88, notes: U/L; Blood bilirubin: (20Dec2021) 1.0 mg/dl; Blood calcium (8.6-10.5): (20Dec2021) 8.7 mg/dl; Blood chloride (100-110): (20Dec2021) 105, notes: mmol/L; Blood creatinine (0.4-1): (20Dec2021) 0.83 mg/dl; Blood glucose (70-100): (20Dec2021) 85 mg/dl; Blood potassium (3.5-5.1): (20Dec2021) 4.1, notes: mmol/L; Blood pressure measurement: (20Dec2021) 110/76; Blood sodium (136-145): (20Dec2021) 141, notes: mmol/L; Blood urea (6-25): (20Dec2021) 18 mg/dl; Carbon dioxide (21-32): (20Dec2021) 28, notes: mmol/L; Eosinophil count (0.0-0.5): (20Dec2021) 0.2, notes: K/uL; Eosinophil count: (20Dec2021) 4%; Full blood count: (13Oct2022) Abnormal; Glomerular filtration rate: (20Dec2021) 73; (20Dec2021) 85; Haematocrit (35.0-47.0): (20Dec2021) 40.0 %; Haemoglobin (11.7-15.5): (20Dec2021) 13.1 g/dl; Heart rate: (20Dec2021) 74; Urinary tract infection without hematuria: (unspecified date) Urinary tract infection without hematuria, site un; Lymphocyte count (1.0-5.1): (20Dec2021) 1.7, notes: K/uL; Lymphocyte count: (20Dec2021) 33%; Magnetic resonance imaging head: (unspecified date) Unknown results; Mean cell haemoglobin (27.0-33.0): (20Dec2021) 29.0 pg; Mean cell haemoglobin concentration (31.0-36.0): (20Dec2021) 32.8 g/dl; Mean cell volume (80-100): (20Dec2021) 89, notes: fL; Monocyte count (0.0-0.8): (20Dec2021) 0.5, notes: K/uL; Monocyte count: (20Dec2021) 4%; Neutrophil count (2.0-8.0): (20Dec2021) 2.7, notes: K/uL; Neutrophil count: (20Dec2021) 54%; Nucleated red cells (0.0-100): (20Dec2021) 0.0; Oxygen saturation: (20Dec2021) 99%; Platelet count (150-400): (20Dec2021) 247; Protein total (5.8-7.6): (20Dec2021) 6.5 g/dl; Red blood cell count (3.90-5.40): (20Dec2021) 4.52, notes: M.uL; Red cell distribution width: (20Dec2021) 13.5 %; Urine analysis: (13Oct2022) Abnormal; Vitamin D (20-80): (20Dec2021) 65 mg/ml; Weight: (unspecified date) 195 lbs; White blood cell count (4.0-11.0): (20Dec2021) 5.1, notes: K/uL. Therapeutic measures were taken as a result of gait inability, illness, fatigue, nausea, muscular weakness, sensory loss, dysarthria, contusion.  Clinical course: Patient was doing well until she became sick with COVID 19 in Jun2022. She took Paxlovid. She got her new COVID booster and Flu vaccine on 03Oct2022. Since then, she has been sick. She feels fatigue; her neck and back feel weak. She was house bound, and often bed bound. She was only able to sit in her chair for about 2 hours at a time. Not able to do much except to read, though even that is difficult. Talking and chewing made her feel nauseous. She felt like she can't do anything. She never lost her sense of taste or smell. She got a new wheelchair from 3 months ago. She stated they did not teach her how to control her wheelchair and use all of the features. She did undergo a seating evaluation prior to the delivery of the chair. She noted that she was sitting unevenly in the chair and that her arm got bruised. She was unable to lower the footrest due to it abutting on the front wheels of the chair. She can't be in the wheelchair for a long period of time because it was not comfortable for her. She reported that she had to go to bed about every 2 hours because she can't stay in her chair for long. She can walk 5-10 feet in her house, but then she started having starts having spasms. She used her chair in her house most of the time. She stated that she can no longer exercise due to her current condition. She was not currently comfortable going to the pool. She believed that she does not have good sensation in her legs. She had a cat that sleeps her legs, and she sometimes can't feel it when her cat was on her legs. She states that her hand needs to be in a particular position, otherwise it feels like a strain. She believes that she was hypersensitive. She stated that talking and singing are difficult for her now, but she has no trouble typing. The patient sits in her chair poorly. The chair was too narrow. Her legs were too high in the chair and the seat does not support her thighs. She was leaning to the right and nearly falling out of the chair on the right. The arm rests are too short. The joystick was misplaced. Patient provided information regarding the adverse event with the use of the product. The Pfizer product had a causal effect to the adverse event. Outpatient medications marked as taking for the 13Oct22 encounter (office visit) with (name withheld): Teriflunomide (Aubagio) 14mg tab, take one tab by mouth daily indications: multiple sclerosis, Roplnlrole (Requip) 0.25mg tab, take 4 tablets orally per day as needed in addition to ropinerole 4 mg, Telmisartan (Micardis) 80mg tab, take one tab by mouth daily, Atorvastatin (Lipitor) 20mg tab, take 1 tablet by mouth every day, Roplnlrole 24hr-xl (Requip xl) 2 mg tab, take one tab by mouth daily at bedtime, Aspirin ec (Ecotrin) 81 mg tab, take one tab by mouth daily, Cholecalciferol (vitamin d3) 5,000 units caps, take 5,000 units by mouth daily, Astaxanthin PO (per oral), take 10 mg by mouth daily.  Multiple vitamins-minerals (multivitamin & mineral po), take 1 tab by mouth daily. Lutein PO (Per oral), take 1 tab by mouth daily, Glucosamine PO (per oral), take 1 tab by mouth daily. Omega 3 PO (per oral), take 1 tab by mouth daily.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 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.