Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Muscle disorder
Clinical narrative: Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.