Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Lung infiltration, Meningoencephalitis herpetic, Mouth ulceration, Multi-organ failure, Neurological examination abnormal
Clinical narrative: Initial and follow up information has been received from a physician and a nurse concerning a male patient (age unknown), who on 04-MAR-2008 was vaccinated with a dose of Varivax (Oka/Merck), subcutaneously (lot number, site and dose not reported) instead of Zostavax (Oka/Merck). The nurse stated that she pulled out the wrong vial and didn't look at it to see it was Varivax (Oka/Merck) and not Zostavax (Oka/Merck). She realized it when she went back that day to look at the lot number and realized she used Varivax (Oka/Merck) and not Zostavax (Oka/Merck) (lot number 656395/0290U). The patient did not have any adverse side effects. On 18-MAR-2008, the nurse called the patient and he "was fine". No product quality complaint was involved. Follow up information has been received on 23-APR-2008 from medical records concerning a 63 year old male patient, non-smoker, with hypertension, hyperlipidemia, non-insulin dependent diabetes mellitus and he had type 1 herpes simplex ulcerations, current active lesions, no known allergies, and no past surgical history who presented to the emergency room with development of acute confusion. Family stated that he has had some minor changes over the last seven to ten days but then developed significant confusional state on 18-MAR-2008 and was brought to the emergency room. He was found to have encephalopathy and he rapidly deteriorated requiring intubation along with development of atrial flutter with a rapid ventricular response. He was initially significantly hypertensive, but then developed hypotension in the Intensive Care Unit. CSF revealed A WBC of 7 and slight elevation in protein. A stat MRI was performed, which showed evidence of temporal lobe, encephalitis, along with sinusitis. Infectious Disease was consulted. Upon admission, his temperature was 101, pulse 88, respiratory rate 14, blood pressure 94/52 while on LEVOPHED at 11 mcg per minute. Examination of the patient revealed a well-developed male sedated on the ventilator. He was atraumatic, normecephalic, pupils reacted very sluggishly to light. He had evidence of mouth ulcerations, his neck was supple with no adenopathy. His lungs were essentially clear and his heart was regular but was in A-flutter with 4:1 block. The patient's abdomen had active bowel sounds, no organomegaly and his extremities showed no cyanosis, clubbing or edema. Neurologically, he was encephalopathic and responded minimally to painful stimuli. Diagnostic testing included a white blood cell count of 17,000, hemoglobin 13, creatinine had now increased to 1.6. A chest x-ray showed evidence of a worsening right lower lobe infiltrate. A MRI of the brain showed evidence of an abnormal signal in the right temporal lobe. The impression of the patient's state was HSV1 meningoencephalitis with the herpes by PCR being positive on the CSF, right lower lobe pneumonia with effusion, history of hypertension and sinusitis. The patient's treatment plan included intravenous Rocephin along with intravenous Acyclovir. The patient remained critically ill and will need to be monitored closely by Neurology. A lengthy discussion with the family occurred and a transfer was advised for further management with neurologic consultation. The patient was discharged from this facility on 19-MAR-2008. On 19-MAR-2008, the critical care consultation records indicated the patient was seen and examined. The chart, data, and chest x-rays were personally reviewed the family was spoken to. The patient's history revealed he was in his usual state of good health until this morning when he developed acute confusion. He was brought to the emergency room and was afebrile. Diagnostic evaluation demonstrated changes on an MRI of the brain consistant with herpes meningoencephalitis. The patient suffered acute hypercapnic and hypoxemic respiratory failure requiring intubation. He also developed atrial flutter with a rapid ventricular response. The patient also required LEVOPHED therapy for refratory hypotension. The patient was currently sedated with propofol on the ventilator. Upon admission, the patient's temperature was 101.2, pulse 82, respiratory rate 14, and blood pressure was 94/52 on LEVOPHED therapy at approximately 11 mcg per minute. Examination of the patient revealed a well-developed, well-nourished, middle-aged male who was sedated on a ventilator. HEENT exam was grossly intact. There was an oral endotracheal tube in place. The patient's trachea was midline, and his ungs demonstrated diminished air entry over the right lower lobe. There was no wheezes, rales or rhonchi detected. His cardiovascular system revealed a regular rate and rhythm and the monitor indicated atrial flutter with 4:1 block. The patient's abdomen was soft, non-tender, nondistended, and without masses. Bowel sounds were hypoactive and his extremities were warm to the touch and did not reveal any clubbing cyanosis or edema. Diagnostic tests included a normal chest x-ray on 18-MAR-2008. A chest x-ray performed on 19-MAR-2008, demonstrated worsening right lower lobe consolidation and pleural effusions. Laboratory tests included white blood cell count 17.4, hemoglobin 13.3, hematocrit 37.8, platelets 247,000, sodium 134, potassium 3.8, chloride 96, bicarbonate 27, BUN 29, and creatinine 1.6, Arterial blood gas reveals a pH of 7.38, PCO2 50.8, pO2 78.2, bicarbonate of 30.3 on assist control, rate 12, tidal volume 650, FIO2 100%, and a PEEP of 5. The patient's assessment included septic shock with multiple organ dysfunction syndrome, HSV meningoencephalitis, acute respiratory failure, right lower lobe pneumonia plus right pleural effusion, acute renal failure, atrial flutter, and uncontrolled type 2 diabetes. It was recommended that the patient receive IV fluid, IV Levophed, IV antibiotics per Infectious Diseases, IV insulin, mechanical ventilator support, increase PEEP and titrate FIO2, and consider throacentesis. At the time of reporting, the patient's outcome is unknown. Additional information has been requested. All available medical records will be provided upon request.  6/9/08and 6/24/08-DC Summary received for DOS 3/18-4/22/08-DC: Herpes Encephalitis. Encephalopathy. Respiratory failure. Pneumonia. Atrial flutter. Hypotension. Euthyroid sick syndrome. Presented with 1 day of confusion after 4-5 days of headache and flu-like symptoms. Endotrach tube, tracheostomy.  mechanical ventilation.