Age: 65.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Areflexia, Back pain, Blood creatine phosphokinase increased, CSF test abnormal, Computerised tomogram normal
Clinical narrative: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 65-year-old female patient who received Influenza vaccine. Co-suspect products included Varicella vaccine and simvastatin for coronary artery disease. The patient's past medical history included transient ischemic attack and acute myocardial infarction. Concurrent medical conditions included hypertension, coronary artery disease, dyslipidemia, pain in extremity, back pain, walking difficulty, tingling of extremity and numbness in feet. On an unknown date, the patient received Influenza vaccine at an unknown dose, Varicella vaccine at an unknown dose and simvastatin 20 mg at an unknown frequency. On an unknown date, the dose was changed to 40 mg at an unknown frequency. On an unknown date, 2 days after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), back pain, pain in extremity, muscle weakness, tendon reflex absent, hypoesthesia, pleocytosis and labeled drug-drug interaction medication error. The action taken with simvastatin was unknown (Dechallenge was unknown). Rechallenge with simvastatin was unknown. On an unknown date, the outcome of the rhabdomyolysis, back pain, pain in extremity, muscle weakness, tendon reflex absent, hypoesthesia, pleocytosis and labeled drug-drug interaction medication error were unknown. The reporter considered the rhabdomyolysis, back pain, pain in extremity, muscle weakness, tendon reflex absent, hypoesthesia, pleocytosis and labeled drug-drug interaction medication error to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of rhabdomyolysis in a 65-year-old female patient who had received unspecified varicella and influenza vaccines (manufacturers unknown). The patient with a past history of transient ischemic attack and the following concomitant medical conditions: hypertension, coronary artery disease status post acute myocardial infarction and dyslipidemia. She was on statins (unspecified) concomitantly that had been increased from 20 to 40 mg one month before. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified varicella vaccine and an unspecified influenza vaccine (dosages unspecified; administration sites and routes unspecified, batch numbers not provided). On an unspecified date, 2 days after the vaccinations, the patient was admitted to hospital with a 3-week history of worsening back and extremities pain accompanied by difficulty in walking and tingling and numbness in both feet. Upon clinical examination on admission she was noted to have severe tenderness in her back and extremities that complicated the procedure. She was found to have rhabdomyolysis according to her laboratory results and she was given a working diagnosis of statin-induced myopathy. Serial neurological examinations performed after her condition worsened while in hospital revealed 2/5 power in her bilateral hip flexors, absent deep tendon reflexes in knees and ankles, reduced pin-prick and light touch sensation up to breast line, as well as vibration and position sensation up to mid legs bilaterally. This was a serious case as the patient required admission. Blood tests performed on admission showed a creatine phosphokinase level more than 2900 and a myoglobin level of 243 (units and ranges not provided). Computed tomography scan was negative and the authors reported that other unspecified investigations to identify secondary causes were inconclusive too. However an analysis of cerebrospinal fluid performed after her deterioration showed pleocytosis and a magnetic resonance imaging revealed intramedullary T2-hyperintensities extending from C2-T8 with posterior patchy enhancement. Initial treatment was not specified but the authors commented that discontinuation of her medication, prompt hydration and close monitoring of her renal function prevented acute renal failure. Outcome of the events was unspecified at the time of reporting. The authors described the event as related to the influenza vaccine. The authors concluded that "since 1987, use of statins has grown to over 100 million-prescriptions/year and at least 1.5 million people/year will experience a muscle related adverse event while on statin. A commonly prescribed medication and annual seasonal flu vaccination is a well predicted combination in most of the daily encounters for a physician. We hope that our case will throw light on this infamous combination effect which will help physicians in preventing renal injury seen in such high risk patients."