Age: 16.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site joint effusion, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female with diabetes, allergy to thimerosal and sulfonamides and a history of previous pneumonia in 2008 who on 20-FEB-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot# 671001/0843AA, 0.5 ml, intramuscularly). Concomitant therapy included NOVOLOG and inhaler as needed. On 22-FEB-2012 the patient was seen in the office with 1 inch area of redness that was hot to touch on the left arm at injection site. The doctor determined it was cellulitis. Also there was a new redness over right collarbone with tenderness and she also had a cough with phlegm and tightness of chest noted at this visit. She had taken AUGMENTIN tablets 2 doses at home. Discontinued AUGMENTIN and ordered ROCEPHIN. Phone call on 23-FEB-2012 reported injection site improving but warmth, pain and redness 1.5 inch area going down toward left elbow making movement difficult. Possible inflammation of underlying tissue. Changed antibiotic to OMNICEF and discontinued ROCEPHIN. Seen in office on 24-FEB-2012 and cellulitis improving, continued OMNICEF and started clindamycin in case of Methicillin-resistant staphylococcal aureus (MRSA). Phone call on 28-FEB-2012 by parent stating the area was spreading with redness and warmth at injection site and pain with movement. Next day the redness was gone but the patient was not moving her arm and had increased pain to shoulder area. Seen in office 29-FEB-2012 with pain in left shoulder and clavicle. In March, 2012 she saw an endocrinologist for her diabetes and unnamed blood work was ordered. On 21-MAR-2012 the blood tests showed inflammation. The patient was also treated with ice and BENADRYL. On 22-MAR-2012, the patient had magnetic resonance imaging (MRI) of her left shoulder which showed fluid in shoulder area with bursitis. She had repeat visit to endocrinologist on 11-MAY-2012. The patient had PREVNAR injection in 2005 with no adverse symptoms noted. At the time of reporting, the patient was recovering. Follow up information was received from a physician concerning a 16 year old female with type 1 diabetes mellitus, reaction to thimerosal in prior vaccine (type uncertain) (rash) and sulfonamide allergy and a history of pneumonia who on 20-FEB-2012 was vaccinated with PNEUMOVAX 23 (left deltoid). Secondary suspect therapy included influenza virus split virion 3v vaccine inactivated (manufacturer unknown), which was given on the same day, in right deltoid. Other concomitant therapy included NOVOLOG. The patient reacted to thimerosal in prior vaccination (type uncertain) and developed rash.  Next day, on 21-FEB-2012, most of left upper outer arm was erythematous, warm and very tender. Temperature 100.7 F. Treated with i.m. ROCEPHIN and oral AUGMENTIN. Next day, on 22-FEB-2012, redness in upper arm improved, but new redness and swelling was seen in clavicle and lower arm near elbow. Fever had resolved. New areas of erythema would begin as others resolved in the arm. AUGMENTIN was stopped and OMNICEF was started. Erythema continued to spread. Clindamycin was added for methicillin-resistant Staphylococcus aureus (MRSA) coverage. By 29-FEB-2012 erythema and warmth had resolved but pain persisted after 1-2 months or so. At the time of reporting, the patient had recovered from left upper arm cellulitis, fever, fatigue and left arm pain. Follow up information was received from the physician concerning the patient with type 1 diabetes mellitus, allergy to thimerosal and sulfonamides and a rash of unknown origin at the time of vaccination, thought to be fungal at the time. On 20-FEB-2012 at 10:55 am, the patient was vaccinated intramuscularly in the left deltoid with 0.5 ml dose of PNEUMOVAX 23 (lot# 671001/0843AA) (also reported as PREVNAR by the physician). On 21-FEB-2012 at 10:00 am, the patient started experiencing pain and swelling in the left arm and clavicle. Magnetic resonance imaging (MRI) and bone scan were ordered by the patient's endocrinologist (the reporting physician did not have the results but had not heard they were abnormal). It took 2 months for the events to fully resolve. On 26-APR-2012, the patient recovered. Pain and swelling in the left arm and clavicle were considered to be other important medical events by the physician, because they required medical intervention. No further information is available.