Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | LA |
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.
Medical History/Concurrent Conditions: Abstains from recreational drugs; Alcohol use; Diabetes mellitus; Dyslipidemia; Ectopic pregnancy (status post laparoscopy); Laparoscopy; Nonsmoker
ATORVASTATIN; METFORMIN; PREDNISONE
Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:384 IU/l; Test Name: cytoplasmic anti-neutrophil cytoplasmic antibody; Result Unstructured Data: Test Result:less than 0.2 IU/ml; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:241 IU/l; Test Name: right thigh skeletal muscle biopsy; Result Unstructured Data: Test Result:consistent with necrotizing; Comments: myopathy, without specific diagnostic features and without features of chronic myopathic disorder.; Test Name: total bilirubin; Test Result: 1.2 mg/dl; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:Greater than 7800 IU/l; Comments: On hospitalization days 1-7; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:5960 IU/l; Comments: On hospitalization day 8; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:5721 IU/l; Comments: On hospitalization day 9; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4155 IU/l; Comments: On hospitalization day 10; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4525 IU/l; Comments: On hospitalization day 11; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4122 IU/l; Comments: On hospitalization day 12; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3979 IU/l; Comments: On hospitalization day 13; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3479 IU/l; Comments: On hospitalization day 14; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3651 IU/l; Comments: On hospitalization day 15; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3933 IU/l; Comments: On hospitalization day 16; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3143 IU/l; Comments: On hospitalization day 17; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:2960 IU/l; Comments: On hospitalization day 18; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:2847 IU/l; Comments: On hospitalization day 19; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3189 IU/l; Comments: On hospitalization day 20; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3094 IU/l; Comments: On hospitalization day 21; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3604 IU/l; Comments: On hospitalization day 22; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3690 IU/l; Comments: On hospitalization day 23; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3855 IU/l; Comments: On hospitalization day 24; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4444 IU/l; Comments: On hospitalization day 25; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4242 IU/l; Comments: On hospitalization day 26; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4147 IU/l; Comments: On hospitalization day 27; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4261 IU/l; Comments: On hospitalization day 28; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4001 IU/l; Comments: On hospitalization day 29; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3874 IU/l; Comments: On hospitalization day 30; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3632 IU/l; Comments: On hospitalization day 31; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3836 IU/l; Comments: On hospitalization day 32; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4240 IU/l; Comments: On hospitalization day 33; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3897 IU/l; Comments: On hospitalization day 34; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3928 IU/l; Comments: On hospitalization day 35; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:4234 IU/l; Comments: On hospitalization day 36; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3672 IU/l; Comments: On hospitalization day 37; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3174 IU/l; Comments: On hospitalization day 38; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3116 IU/l; Comments: On hospitalization day 39; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3661 IU/l; Comments: On hospitalization day 40; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3189 IU/l; Comments: On hospitalization day 41; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:3714 IU/l; Comments: On hospitalization day 42; Test Name: creatine kinase MB; Result Unstructured Data: Test Result:292.3 IU/l; Test Name: thyroid-stimulating hormone; Result Unstructured Data: Test Result:7.18 uiU/mL; Test Name: chest x-ray; Result Unstructured Data: Test Result:demonstrated no abnormalities.; Test Name: CSF glucose; Test Result: 66 mg/dl; Test Name: CSF protein; Test Result: 24.7 mg/dl; Test Name: CSF RBC; Result Unstructured Data: Test Result:1; Test Name: Cerebrospinal fluid (CSF) analysis; Result Unstructured Data: Test Result:showed colorless fluid with; Comments: CSF protein of 24.7 mg/dl, CSF WBC 0 x 10^9/L, CSF RBC 1, CSF glucose 66 mg/dL. The CSF results were not consistent with Guillain-Barre syndrome.; Test Name: CSF WBC; Result Unstructured Data: Test Result:0 x10 9/l; Test Name: HbA1c; Test Result: 6.3 %; Test Name: HLA class I immunohistochemistry; Test Result: Negative ; Comments: provided support for nonimmune myopathy.; Test Name: magnetic resonance image without contrast of cervical spine/lumbar spine/extremities; Result Unstructured Data: Test Result:demonstrated mild degenerative changes in the; Comments: 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.; Test Name: Physical exam; Result Unstructured Data: Test Result:showed the patient had bilateral proximal weakness; Comments: 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.; Test Name: Kidney function; Result Unstructured Data: Test Result:remained within normal limits; Comments: throughout the hospitalization; Test Name: rheumatoid factor; Result Unstructured Data: Test Result:less than 10 IU/ml; Test Name: anti-smooth muscle antibody; Result Unstructured Data: Test Result:14 units; Test Name: free T4; Result Unstructured Data: Test Result:1.15 ng/dL; Test Name: white blood cell (WBC) count; Result Unstructured Data: Test Result:10.4 x10 9/l