Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea
Clinical narrative: Polymyalgia Rheumatica; flu-like symptoms; pain; elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); fatigue; weakness; stiffness; unable to get up from the bed; headache; blurry vision; decreased range of motion in the shoulder and hip joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "cerebrovascular accident" (unspecified if ongoing); "stomach ulcers" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "migraines" (unspecified if ongoing); "chronic urinary tract infection" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "diagnosis of myalgias" (unspecified if ongoing), notes: diagnosis of myalgias caused by the vaccine; "chronic rheumatic diseases" (unspecified if ongoing), notes: has been well-tolerated by patients with chronic rheumatic diseases. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms"; PAIN (non-serious), outcome "not recovered"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown" and all described as "elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)"; FATIGUE (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness"; BEDRIDDEN (non-serious), outcome "unknown", described as "unable to get up from the bed"; HEADACHE (non-serious), outcome "unknown"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "decreased range of motion in the shoulder and hip joints". The patient underwent the following laboratory tests and procedures: Biopsy artery: Negative, notes: She had left and right temporal artery biopsies, which were negative for any histopathological abnormalities indicating no GCA; Blood bicarbonate (23-29): 25 mEq/l, notes: Reference Range: 23-29 mEq/L); Blood chloride (95-105): 107 mEq/l, notes: Reference Range: 95-105 mEq/L); Blood creatinine (0.6-1.2): 0.9 mg/dl, notes: Reference Range: 0.6-1.2 mg/dl; Blood potassium (3.5-5.0): 4.0 mEq/l, notes: Reference Range: 3.5-5.0 mEq/L); Blood sodium (135-145): 136 mEq/l, notes: Reference Range: 1 35-145 mEq/L); Blood thyroid stimulating hormone (0.5-5.0): 3.5 MiU/L, notes: Value: 3.5 mil international units/liter(mIU/L) Reference Range: (0.5-5.0) mIU/L; Blood urea (5-20): 15 mg/dl, notes: Reference Range: 5-20 mg/dl; Computerised tomogram: Unknown Result, notes: computed tomography (CT) scan; C-reactive protein (0-10): 50 mg/l, notes: Value: 50 milligram/liter (mg/L) Reference Range: (0-10 mg/L); 29 mg/l, notes: Value: 29 (mg/L) Reference Range: (0-10 mg/L); Haemoglobin (12-16.0): 13 g/dl, notes: Reference Range: (12-16.0 g/dl); Platelets (150-450): 299 uL, notes: Reference Range: (150-450 x 10 /microliter); temporal artery US: Unknown result, notes: temporal artery US; Positron emission tomogram: Unknown result, notes: positron emission tomography (PET) can be obtained; Red blood cell sedimentation rate: 108, notes: Value: 108 millimeter/hour (mm/hr) Reference Range: (female Less than 20mm/hr); 54, notes: Value: 54 (mm/hr) Reference Range: (female Less than 20mm/hr); White blood cell count (4.5-5.5): 5.0 uL, notes: Reference Range: (4.5-5.5 x 10 /microliter). Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical information: The patient mentioned that about 10 days after receiving the BioNTech-Pfizer COVID-19 booster vaccine (BNT162b2), she started developing extreme fatigue, widespread pain throughout her body, and generalized weakness. She mentioned severe pain and stiffness in the shoulder and hip girdle to the point that she was unable to get up from the bed and had to use a cane for ambulation. She also endorsed a band-like headache around her temples as well as blurry vision. No jaw claudication symptoms were reported. Initially, she had flu-like symptoms after the COVID-19 booster that gradually resolved, but the body aches and fatigue continued. Her musculoskeletal examination showed decreased range of motion in the shoulder and hip joints but was unremarkable for any joint effusion, synovitis, or tenderness. Muscle strength was 5/5 in the upper and lower extremities. No temporal tenderness or bulging was noted. Initial laboratory studies showed normal complete blood count, basic metabolic profile, and thyroid function tests. Her Inflammatory markers were extremely elevated; ESR was 108 millimeters/hour and CRP was 150 milligram/liter. With high clinical suspicion of PMR and giant cell arteritis (GCA), the patient was started on prednisone 60 mg daily, and a temporal artery biopsy was scheduled. She had left and right temporal artery biopsies, which were negative for any histopathological abnormalities indicating no GCA. She was instructed to taper her prednisone dose gradually. At her two-week follow-up appointment, the patient showed a significant response to prednisone treatment, with improvement in her shoulder and hip girdle pain and stiffness. Her ESR improved to 54 and her CRP improved to 29. Her headache and blurry vision persisted despite a negative temporal artery biopsy, and she was referred to an ophthalmologist for further evaluation of blurry vision.   Conclusions: The temporal relationship between COVID-19 vaccination and PMR has yet to be established, but our case report will add to the literature review. We hypothesize that the COVID-19 vaccine triggered the auto inflammatory state in our patient leading to PMR. Myalgias are a commonly reported adverse effect of the COVID-19 vaccine. We emphasize that physicians should pay attention to persistent myalgias and obtain ESR and CRP levels when appropriate to evaluate possible PMR, which response well to corticosteroid treatment. However, these cases are rare and should not prevent the population from receiving the vaccine, as the benefits of the COVID-19 vaccine outweigh the risks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.