Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, Blood urine present, Borrelia test negative, Chromaturia, Emotional distress
Clinical narrative: Rhabdomyolysis; flu-like symptoms; distress; complaining of severe myalgias in the shoulders and legs; palpitations; dark colored urine; This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 60-year-old female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.  Concurrent medical conditions included hypertension and thalassemia (minor).   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, 1 day after receiving Herpes Zoster vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization), emotional distress (serious criteria hospitalization), myalgia (serious criteria hospitalization), palpitation (serious criteria hospitalization) and urine discoloration (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, influenza-like symptoms, emotional distress, myalgia, palpitation and urine discoloration were unknown.   The reporter considered the rhabdomyolysis, influenza-like symptoms, emotional distress, myalgia, palpitation and urine discoloration to be probably related to Herpes Zoster vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Rhabdomyolysis, in a female patient aged 60-year-old, who was vaccinated with unspecified Recombinant Zoster vaccine (manufacturer unknown) for prophylaxis.  The patient had past medical history of hypertension and thalassemia minor. No information on patient family history or concomitant medication was reported.  On an unknown date, the patient received unspecified recombinant zoster vaccination in her left deltoid (administration route unspecified, dosage unknown, batch number not provided), did not have any immediate adverse effects vaccine. The age at vaccination was not reported but it could be between 59 years or 60 years at the time of vaccination.  On an unknown date, next day after vaccination, the patient called reporting flu-like symptoms. Six days after administration, the patient presented in distress, complaining of severe myalgias in the shoulders and legs, palpitations, and dark colored urine. The patient denied dysuria, frequency, urgency, and was afebrile. Urinalysis revealed 3 plus (+) blood and 2+ protein. Laboratory studies showed a creatinine phosphokinase (CPK) level more than 23,000 (iU)/L with significantly elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of 1265 U/L and 747 U/L, respectively. Thyroid stimulating hormone, Lyme disease titers, antinuclear antibody (ANA), rheumatoid factor, viral panel, blood cultures, and further immunologic workup were unremarkable. The patient was admitted to the hospital for severe rhabdomyolysis. The patient denied any previous history of rhabdomyolysis, recent trauma, immobilization, statin use, toxic exposure, and new medications. The patient's symptoms, CPK, and AST/ALT improved over the next several days with aggressive hydration and the patient was discharged in stable condition. At one month follow up, the patient reported complete resolution of myalgias and denied any recurrence of symptoms. The second dose of the recombinant vaccine was not administered. The Naranjo Score was six, characterizing rhabdomyolysis for this patient was a probable adverse reaction. The case was considered as serious due to hospitalization. The authors commented "In this patient, there was no evidence of the common precipitating factors of rhabdomyolysis. While it may be difficult to definitively establish a direct relationship between a specific exposure and an adverse outcome, methods exist to determine its likelihood. Depending upon the cumulative score of 10 questions, a possible adverse reaction is classified as definite, probable, possible, or doubtful. For this patient, positive findings include the following: the adverse event appeared after the drug was given, the adverse event improved after the drug was discontinued, alternative causes were ruled out, and objective evidence of the adverse event was available. These results yield a Naranjo Score of six, characterizing rhabdomyolysis in this case as a probable adverse reaction. Although the exact mechanism of this reaction is not known, we believe an exaggerated immune response to be most likely. The association between rhabdomyolysis and the vaccination is largely based upon the patient's history and exclusion of other common precipitating factors such as trauma or immobilization. Considering the possible lethal complications of rhabdomyolysis and the widespread use of the recombinant zoster vaccine, this potential serious outcome must be acknowledged and symptoms not ignored. Perhaps, patients with a recent history of risk factors such as trauma should delay in being vaccinated. At the least, patients reporting significant myalgias after administration should be tested for rhabdomyolysis".