Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood pressure decreased, Dysarthria, Muscle spasms, Paraplegia
Clinical narrative: Information has been receive for interferon beta-lb. It was reported that a 52 year old white female who on 9/22/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Suspect therapy included SC interferon beta-lb for multiple sclerosis, initiated in July 2003 (at time of event, the patient was receiving dmIU every other day, also reported as 2mIU ever other day). Concomitant therapy included acetaminophen on an as needed basis, citalopram hydrobromide for depression, tizanidine for spasms, corticosteroids, folic acid, lisinopril, meclizine, and albuterol. Concurrent conditions included multiple sclerosis for 20 years from 1983 until present (MS symptoms include: inability to use legs, spasms, constipation, upper extremity weakness, significant speech disturbance, decreased motor skills, diplopia, ocular difficulties, dysphagia, hemiparesis, decreased cognitive function, muscle spasms of hands) (patient has been on unspecified steroid therapy from 1983 until May 2003), depression, a remote history of hypertension, a fish, fowl, and nut allergy, and an allergy to Sulfa and Iodine (reaction not specified). It was also noted that the patient is essentially bedridden and/or wheelchair dependent. The patient also has a past medical history of fracture of the shoulder and pelvis as a result of a fall while getting out of her wheelchair on her own in June 2003 (hospitalization and extended in-patient rehab stay required), alcoholism (currently abstains from alcohol), and the patient is a non-smoker. There is no previous history of cardiac disease, diabetes, thyroid disorder, seizure, cancer or autoimmune disease. On 9/24/03, two days after vaccination, the patient was found at home with generalized weakness, worsening speech, and stupor. Upon arrival to the emergency room, the patient's blood pressure was 69/43 mmHg with a mild tachycardia. She was oriented to place and person, but not to time. Speech was dysarthric and a right internuclear paraplegia was noted. Hemodynamic shock was diagnosed and volume resuscitation was carried out. It was felt that the adrenal insufficiency was possible, as the patient had been on steroids for 20 years (1983 through May 2003). On 9/24/03, the BETASERON was discontinued. Ceftazidime was administered until blood and urine cultures were reported as negative on 9/26/03. The chest x-ray was normal, showing no acute disease of the chest; no CHF or pneumonia. Intravenous fluid resuscitation with normal saline and the administration of IV hydrocortisone resulted in resolution of the hypotension and improvement of menta status. Hydrocortisone was reduced from 100mcg to 40mg. Titration doses of oral prednisone from 60mg to 20mg were initiated for long term use. In September 2003, a MRI brain demonstrated lesions consistent with MS. On 9/29/03 to October 2003, the patient was given interferon beta-lb 4mIU, every 2 days, SC. The patient's MS was described as end-stage; severe, advanced and progressively worse, with neurological deficits characterized by diplopia, and inability to perform activities of daily living and muscular spasms of the hands. On 9/23/03, also reported as 9/25/03, a CT of the brain demonstrated atrophy, with posterior fossa changes of small vessel ischemia, probably advanced for the patient's age. Abnormal lab data included an elevated cortisol level on 9/24/03:preACTH = 32.0 mcg/dL and post ACTH = 39.2 mcg/dL. All other lab data is listed below. The patient was discharged from the hospital on 9/26/03, after a 3 day hospitalization, with a recommendation for long term care placement. She was transferred to an in-patient rehab facility for upper and lower extremity strengthening. Anticipated duration of stay was reported as 2-3 weeks (anticipated date of discharge was 10/9/03). Discharge medications included hydrocodone bitartrate, paracetamol, baclofen, tizanidine, prednisone, docusate sodium, lactulose and citalopram hydrobromide. From 10/03 to present, the patient was given interferon beta-lb 8mIU, every 2 days, SC. After the reintroduction of interferon beta-lb, the event did not recur. It was noted that the patient's husband felt that the event might have been related to a pneumonia shot that the patient received on 9/22/03. This information contained the following adverse experience: multiple sclerosis end-stage, severe, advanced and progressively worse. This was originally reported by a physician.