Age: 37.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dizziness, Headache, Hyperhidrosis, Hypertension, Hypoaesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 37 year old white non drinking (also reported to use alcohol regularly, 2-3/day), male, chef, with no known allergies, who lives with his wife, performs his own activities of daily living and is independent, with a past surgical history of an open reduction with an internal fixation of the right lower leg, who has reflux disease, multiple sclerosis for the past two years, inflammatory acne, migraines, joint pain in the pelvic and thigh region, and who formerly had smoked one and a half packs per day since he was fourteen yrs old, and who has a family history of a father with Parkinson's disease, who on 09Nov05 was vaccinated IM into the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Concomitant vaccine administered on the same day included a dose in the left arm of influenza virus vaccine live (unspecified). The nurse reported that the pt self administered interferon beta 1a (Avonex), into the right arm, IM, later in the same day. The nurse stated that the pt had been taking interferon beta la (Avonex), once a week, for about 4 or 6 months (also reported as a year and a half). Concomitant therapy also included lansoprazole (Prevacid) and tetracycline hydrochloride, 500 mg, BID, PO, for the treatment of acne. It was noted that the pt had not had any problems with cellulitis or true injection site reaction in the past. On 09Nov05 the pt developed cellulitis and was hospitalized. The pt had a bacterial culture test which had no problem. The pt was reported as recovered. There was no product quality complaint involved. Follow up information from a physician indicated that on the morning of 09Nov05 the pt felt nauseous with chills, sweating, and fever. The pt experienced a headache and dizziness without hallucinations. It was reported that the pt normally had a feeling of fever and nauseousness the day after his interferon beta 1a (Avonex) shots but this was reportedly much worse than normal. The pt had received the immunization shots before this was reportedly much worse than normal. The pt had received the immunization shots before but never received all three shots in one day before. The pt took naproxen sodium (Aleve) with no relief. The pt's symptoms continued to worsen as the day progressed. The pt then went to the ER where he was started on ceftriaxone sodium (Rocephin) and IV fluids. The pt had presented with a fever of 39 deg C. The pt was treated with acetaminophen (Tylenol), 1g, oral administration. The pt also had three oval shaped areas of warm, erythematous macules over the right deltoid. The pt originally presented with one near the axillary border but upon the examination the pt had two more areas of erythema. The lesions were approx 3cm x 3cm ovals with a larger lesion measuring around 5cm x 3cm. The pt also had a scabbed over burn mark on his right forearm that was clean and dry without any redness or discharge. Upon evaluation, the pt's redness had diminished and was more diffuse compared to the day prior. A review of systems was performed in the hospital on 10Nov05. The review of the head, eyes, ears, nose and throat indicated that the pt had a headache, denied any migraines or head trauma, denied any changes in vision, there was diplopia or loss of visual fields. The review of the ears, nose, and throat indicated that the pt denied any sore throat, congestion or epistaxis. The review of the neck indicated that the pt did not report daily neck stiffness and pain, denied any masses or histories of bruits. The respiratory review indicated that the pt denied any shortness of breath, cough, or hemoptysis. The cardiac review indicated that the pt denied any chest pain, dyspnea on exertion, orthropnea, or palpitations. The gastrointestinal review indicated that the pt reported recent nausea, but denied any vomiting over the past 24 hrs. The genitorinary review indicated that the pt reported weakness and numbness in his hands. His left was greater than his right. The pt did report light headedness, usually after his interferon beta la (Avonex) shots. The musculoskeletal review indicated that the pt reported general arthralgias on a daily basis. The endocrine review indicated that the pt denied any polydipsia, polyphagia, or polyuria. The heme review indicated that the pt denied any ease of bruising, history of deep vein thrombosis, or pulmonary edema. Upon physical examination on 10Nov05 the pt's temp was 98.8, blood pressure was 108/64, pulse was 99, respiratory rate was 18, and O2 saturations were 96% on room air. The pt's extraocular muscles were intact, pupils were equally reactive to light and accommodation, mucosa was pink and moist. The pt's neck was soft, nontender, and no adenopathy was noted. The pt's cardiac examination showed regular rate and rhythm, first heart sound, second heart sound and no murmurs, rubs or gallops. The pt was clear to auscultation bilaterally. There were no wheezes or crackles. The pt's abdomen was soft and non tender with positive bowel sounds at four quadrants. The upper and lower extremity pulses at radial and dorsal pedis were 2+. There were right sided, deltoid, erythematous, macules that were warm to the touch. There was a right forearm burn with signs of good healing. There was no discharge or erythematous base. The assessment was a febrile illness that was secondary to cellulitis, bacteremia was ruled out. The plan was to continue with ceftriaxone sodium (Rocephin), 1g, every 24 hrs, IV. The results of the blood cultures were awaited. Liver function, urinalysis, sedimentation rate, and c reactive protein were cultures were to be checked. The pt was to be observed overnight. A consulting physician indicated that, on 10Nov05, the pt was seen in the ER where he was found to be febrile to 39 and with a white count that was over 20,000. There was a significant cellulitis over the arm and he was admitted for further management. The pt was ultimately admitted on 10Nov05 and started on IV ceftriaxone sodium (Rocephin), 1g, IV, every 12 hrs. The physician noted that despite the IV ceftriaxone sodium (Rocephin) the pt's white count remained high the following day and he remained febrile to 101. It was decided to add some empiric vancomycin 1g IV every 12 hrs. The pt indicated to the physician that over the last day he felt markedly improved. The pt's arm was less tender and his fever was down. His white count was down slightly from 24,000 to 21,000. The review of systems was negative for sore throat, cough, shortness of breath, abdominal pain, diarrhea, dysuria, urgency, frequency, skin rash, or joint symptoms. A physical examination was unremarkable with the exception of a very large area of erythema, warmth and marked tenderness with deep palpation of the muscle area over the right deltoid. The impression was that the pt had a localized cellulitis without abscess formation over his right deltoid area, in the area where he received both the pneumococcal 23v polysaccharide vaccine and interferon beta-1a (Avonex). The physician did not think that this was just a primary injection reaction, and that he may have developed a cellulitis as a result of one of his injections and it was difficult to know whether it was the pneumococcal 23v polysaccharide vaccine or the interferon beta-1a (Avonex). It was reported that the pt seemed to be clinically improving, particularly over the last 24 hrs with vancomycin initiated. The physician indicated that the event may have been a staphylococcal etiology and in particular methicillin resistant Staphylococcus aurous. It was noted that a contaminated needle could not be ruled out. The physician recommended to continue the pt both on vancomycin and ceftriaxone sodium (Rocephin). The pt was to be rechecked to make sure there was no evidence of myositis. A discharge summary from a physician indicated that the pt was discharged on 14Nov05 with a diagnosis of right deltoid cellulitis, resolved leukocytosis, and multiple sclerosis. The discharge medications were linezolid (Zyvox), 600mg, twice a day for the next 10 days, and acetaminophen (+) hydrocodone bitartrate (Vicodin), 1-2 tablets, every 6 hrs, as needed. A physician indicated that the pt presented for a follow up visit on 22Nov05. It was noted that the pt had not worked since 19Nov05 and was planning to return on 24Nov05. It was also noted that the pt had not given himself his usual doses of interferon beta-1a (Avonex). It was reported that the pt had multiple concerns concerning whether to continue with interferon beta 1a (Avonex) and whether to seek the opinion of a sub specially neurologist who works with multiple sclerosis primarily. The assessment for the cellulitis and abscess was that the pt appeared to be significantly improved and his acute syndrome was nearly resolved. The physician noted that he should complete his antibiotic course. The right supraclavicular node would likely remain somewhat tender for the next 1-2 weeks but should resolve without any discomfort. The physician reported that he had sent the vial containing pneumococcal 23v polysaccharide vaccine to the manf for gram stain and culture, in order to identify any possible pathogens which the vaccine might have contained. The physician suspected that the cellulitis was a result of being immunocompromised and probably related to the combination of the two injections given in a short temporal proximity. The physician recommended that the pt wait until 2 weeks had passed since the last dose of antibiotic before restarting interferon beta-1a (Avonex) injections, then continue per routine. It was reported that the pt recovered fully on 22Nov05. Cellulitis was considered to be immediately life threatening, disabling and other important medical event by the reporter (OMIC). A lot check was requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition there were no open Quarantines registered against this lot/fill. Additional information is not expected.