Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood thyroid stimulating hormone, CSF glucose, CSF protein
Clinical narrative: Vaccine-Induced Rhabdomyolysis; This is a literature report .  A 53-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The following information was reported: RHABDOMYOLYSIS (caused hospitalization) with onset 2021, 45 days after the suspect product(s) administration, outcome "recovered", described as "Vaccine-Induced Rhabdomyolysis". The patient was hospitalized and prolonged hospitalization for rhabdomyolysis (hospitalization duration: 43 day(s)). The patient's medical history, historical vaccinations, concomitant medications, and clinical course was reported as follows: The patient initially presented to the hospital after 3 weeks of progressive proximal extremity weakness. The patient reported bilateral proximal upper and lower extremities pain, which started with the left lower extremity and progressed to the right lower extremity. One week later, the patient reported right upper extremity pain followed by left extremity pain. She noted a decrease in exercise capacity, from 30 minutes on the treadmill to 10-15 minutes. She denied prior similar symptoms. The pain was described as muscle soreness from a workout that occurred predominantly with movement. Neck and lower back pain were endorsed but the patient attributed these findings to a sedentary job. The patient received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine), in early 2021, with both vaccines given in the left arm. Adverse effects reported from the vaccine included nausea and vomiting that resolved after 2 weeks. Presentation of symptoms occurred about 45 days after the second dose. The patient denied fever, chills, headache, recent trauma, shortness of breath, recent upper respiratory infections, gastrointestinal infections, pain in extremities, chest pain, rashes, recent travels, camping, new diet/foods (honey), medication changes, family history or cancers personally or in family. The patient had a past medical history of diabetes mellitus and dyslipidemia. Medications included atorvastatin 80 mg which was decreased to 40 mg, due to left extremity soreness, about 45 days after the second dose, and metformin 500 mg. Of note, the patient had been on atorvastatin for over 3 years. Surgical history included ectopic pregnancy status post laparoscopy. She had no known drug allergies. The patient reported she consumed alcoholic beverages on occasion but denied smoking or recreational drug use. Physical exam showed the patient had bilateral proximal weakness in the upper and lower extremities, which was specifically pronounced bilaterally in the thighs. She was also noted to have pronounced tenderness on passive and active movements of bilateral upper and lower extremities. Initial labs included creatine kinase of 7800 U/L initially, which trended down during hospitalization. Other labs included, aspartate aminotransferase 241 U/L, alanine aminotransferase 384 U/L, total bilirubin 1.2 mg/ dL, white blood cell (WBC) count 10.4 x 109/L , thyroid-stimulating hormone 7.18 uUI/mL with free T4 1.15 ng/dL, creatine kinase MB 292.3 U/L, HbA1c 6.3%, rheumatoid factor less than 10 IU/ mL, cytoplasmic anti-neutrophil cytoplasmic antibody less than 0.2 IU/mL, and anti-smooth muscle antibody of 14 units. Cerebrospinal fluid (CSF) analysis was obtained, which showed colorless fluid with CSF protein of 24.7 mg/dl, CSF WBC 0 x 109/L, CSF RBC 1, CSF glucose 66 mg/ dL. The CSF results were not consistent with Guillain-Barre syndrome. Imaging consisted of chest x-ray which demonstrated no abnormalities. A magnetic resonance image without contrast of cervical spine/ lumbar spine/extremities demonstrated mild degenerative changes in the discs throughout the region with mild diffuse annular disc bulging and spondylosis at C5-6 and C6-7. Lumbar region findings included mild degenerative changes in discs, otherwise, with no other acute abnormality. Extremities were noted to have no significant abnormality. A right thigh skeletal muscle biopsy was ordered, which was consistent with necrotizing myopathy, without specific diagnostic features and without features of chronic myopathic disorder. HLA class I immunohistochemistry was negative which provided support for nonimmune myopathy. Atorvastatin was discontinued on day 1 of hospitalization. The patient received aggressive intravenous hydration consisting of normal saline at 150 cc/hr, increased to 200 cc/hr on day 2 of hospitalization, and sustained at 200 cc/hr until day 41. Kidney function was monitored throughout the hospitalization and re¬mained within normal limits. Strict intake and output were documented along with volume status evaluation. The patient also received prednisone from day 1 to day 42 of hospitalization (30-40 mg PO daily) due to suspicion of an autoimmune process. She was also given intra-venous immunoglobulin from day 37 to day 42 and was monitored for possible improvement in creatine kinase. The patient symptomatically improved throughout the hospitalization and was discharged home on Day 43 with close follow-up. Therapeutic measures were taken as a result of rhabdomyolysis. Per the author's discussion: There are few published cases of similar symptoms with COVID-19 vaccine. Unlike prior similar cases, our patient demonstrated a delayed adverse effect, approximately 5 weeks after injection of the second vaccine dose. This could be attributed to the efficacy of the second dose of vaccine with age, cellular, and humoral immune responses as contributing factors, with studies demonstrating peak IgA/ IgG approximately 5 weeks. Rhabdomyolysis secondary to vaccines has been previously described with the influenza vaccine. These cases displayed similar histopathological features on biopsy as our patient: a small number of lymphocytes, almost exclusively associated with necrotic and regenerating myofibers; minimal inflammation, with negative HLA Class I immunohistochemistry, supporting a non-immune (non-inflammatory) myopathy.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event Rhabdomyolysis.  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.