Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhabdomyolysis, Specific gravity urine normal
Clinical narrative: A report was received from a literature source, concerning a 29 years old female patient. The follow up information was incorporated in narrative. The patient has no past medical history. She does not smoke, she drinks alcohol occasionally and performs eccentric exercise. Family was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST on 01-Oct-2009 and inactivated H1N1 vaccine (Novartis) on 23-Nov-2009. (Initial report described second vaccine as nasal mist live virus H1N1 vaccine, but lot identifier provided in follow-up corresponded to a Novartis H1N1 vaccine.) The patient who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time she reported that she had received the H1N1 vaccine were three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66, 000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophosphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporter, this patient was used to eccentric exercise, it seemed rate that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. The patient had no further episodes of rhabdomyolysis, but her recovery was incomplete. She had mild residual upper body weakness. However she was able to meet requirements for deployments, including pushups and has deployed. The authors initially wrote that given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it was hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabomyolysis; however, further investigation revealed that the patient had received an inactivated parenterally administered H1N1 vaccination approximately three weeks after receiving FLUMIST, not a second five virus vaccine. The outcome of the event was recovering. The reporter assessed the event of exertional rhabodmyolysis as related to FLUMIST and live-virus influenza vaccines. Additional information was received on 02-Apr-2012 and incorporated in the narrative: The follow-up information received on April 2, 2012, disclosed both vaccination dates and lot numbers. Although neither lot number was valid for any MedImmune vaccine, the first would correspond to a valid FLUMIST lot number by deleting one digit. The lot number for the H1N1 vaccine differed from the format of valid MedImmune vaccine lot numbers; however, it matched a lot number identified in two VAERS reports for Novartis H1N1 vaccine, which had been administered by the military in the same time frame. Accordingly, this patient apparently received FLUMIST first and then an inactivated parenterally administered H1N1 vaccination approximately three weeks later. Assessment of the serious criteria for the report was as follow: Hospitalization. The reporters assessed the event of exertional rhabdomyolysis was causality related to FLUMIST and H1N1 Vaccine. Follow-up of insignificant information received by AstraZeneca 02-Apr-2012: updated reporters details.